Idiopathic Pulmonary FibrosisPhase 1NCT03069989

Single Doses of GSK3008348 in Idiopathic Pulmonary Fibrosis (IPF) Participants Using Positron Emission Tomography (PET) Imaging

A Phase 1 study testing GSK3008348 and [18F]-FBA-A20FMDV2 in people with Idiopathic Pulmonary Fibrosis, run by GlaxoSmithKline at 3 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Idiopathic Pulmonary Fibrosis
What is being tested?: GSK3008348 and [18F]-FBA-A20FMDV2
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 3 sitesUnited Kingdom
Study dates: 13 Jun 2017to 18 Jul 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male participants aged >= 50 years, and female participants aged >=55 years, at the time of signing the informed consent.
Diagnosis of definite or probable IPF as determined by a responsible and experienced chest physician and based on established criteria defined by the American Thoracic Society/European Respiratory Society Internationale Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias.
Ambulant and capable of attending outpatient visits.
FVC > 50 percent predicted and DLCO > 40 percent predicted.
Body weight >= 45 kilograms (kg) and body mass index (BMI) within the range 18.0-35.0 kg/square meter (inclusive).
Male and female

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Male participants: A male participant must agree to use contraception as detailed in this protocol during the study and for at least 90 days after the follow up visit, and refrain from donating sperm during this period.
Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP) as defined in the protocol.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions, listed in the informed consent form (ICF) and in this protocol.

Who cannot join

ALT and bilirubin > 1.5x upper limit of normal (ULN; isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35 percent).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT corrected (QTc) > 450 milliseconds (msec), or QTc > 480 msec in participants with Bundle Branch Block.
Current IPF exacerbation, or upper or lower respiratory tract infection on admission to the clinical unit.
History of or suffers from claustrophobia, or unable to lie flat and still on their back for up to 2 hrs in the PET scanner.
Extent of emphysema greater than the extent of fibrotic change on High-Resolution Computed Tomography (HRCT) scan, based on investigator judgment.

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FEV1/FVC ratio < 0.70 at screening (post-bronchodilator).
History of sensitivity to the study treatment, or components thereof, or a history of drug or other allergy that, in the opinion of the investigators or Medical Monitor, contraindicates their participation.
Any current oro-pharygneal disease or disorders as judged by the investigator.
Currently taking pirfenidone or nintedanib, or received pirfenidone or nintedanib within 30 days of the first dose of study treatment.
Taken, within 7 days or 5 half-lives (whichever is longer) before the first dose of study treatment, organic anion transporter (OAT) substrates with a narrow therapeutic index (example: methotrexate and tenofovir), vitamins, or dietary or herbal supplements, unless in the opinion of the investigator and sponsor the supplement will not interfere with the study medication.
Long-term continuous home oxygen therapy (use of oxygen that is only intermittent and for symptom relief is acceptable).
Participation in a clinical trial and receipt of an investigational medicinal product within the following time period before the first dose in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than 4 new investigational medicinal products within 12 months before the first dose.
Presence of Hepatitis B surface antigen (HBsAg) at screening, or positive Hepatitis C antibody test result at screening or within 3 months before the first dose of study treatment.
Note: participants with a positive Hepatitis C antibody test because of previous, resolved disease can be enrolled if a confirmatory negative Hepatitis C Ribonucleic Acid (RNA) test is obtained.
Previous or current exposure to animals that may harbour Food and Mouth Disease Virus (FMDV2).
Previous long term (>= 3 months) residence in a country where FMDV2 is endemic (such as certain areas of Africa, Asia and South America.
Where participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within 56 days.
History of drug or alcohol abuse that in the opinion of the investigator affects their participation in the study.
Exposure to ionizing radiation in excess of 10 Millisievert (mSv) above background over the previous 3 year period as a result of occupational exposure or previous participation in research studies. Clinically justified (therapeutic or diagnostic) exposures are not included in the exposure calculation.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

GSK Investigational Site
London, SW3 6HP
GSK Investigational Site
London, WC1E 6JF
GSK Investigational Site
London

Other trials in United Kingdom

About this study

Official title: A Study of Single Doses to Evaluate the Safety, Tolerability, Pharmacokinetics and Target Engagement of Nebulised GSK3008348 in Idiopathic Pulmonary Fibrosis Patients, Using Positron Emission Tomography (PET) Imaging

GSK3008348 is being developed as a treatment for IPF. A first-time-in-human study showed that single nebulized doses of 1-3000 micrograms (mcg) GSK3008348 in healthy volunteers were well tolerated, with pharmacokinetic (PK) exposures within the defined limits set in the protocol. The proposed study is a 2-cohort study of single doses, intended to evaluate the safety, tolerability and PK of the drug in participants with IPF not currently treated with pirfenidone or nintedanib, and to obtain preliminary information on target engagement. Cohort 1 will be a 2-period, randomized, double-blind, placebo-controlled group with at least 7 days washout between doses, and follow-up period of up to 7-14 days. Cohort 2 is optional. It will be designed to further explore safety and to provide additional information on the target engagement profile of GSK3008348. The total duration of the study will be up to 62 days.

Conditions: Idiopathic Pulmonary Fibrosis
Being tested: GSK3008348, Placebo, [18F]-FBA-A20FMDV2
Keywords: Tolerability, IPF, PET imaging, Idiopathic Pulmonary Fibrosis, Safety, Pharmacokinetics, Double-blind
Medical subject headings: Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK3008348Drug
Solution for nebulisation. Available as clear colorless to pale yellow colored solution in a 5mL vial with 20 millimeter (mm) stopper and aluminium seal yellow colored solution in a 5mL vial with 20 millimeter (mm) stopper and aluminium seal.
PlaceboDrug
Solution for nebulisation. Available as clear colorless to pale yellow colored solution in a 5mL vial with 20mm stopper and aluminium seal.
[18F]-FBA-A20FMDV2Drug
Radio-labeled peptide ligand for PET scan. Available as intravenous (IV) infusion, 20 mL.

Study groups in NCT03069989
Study group	Role	What they receive
Cohort 1 GSK3008348	Experimental	Participants will receive a single nebulized dose of GSK3008348 during each of 2 planned dosing periods and up to 3 microdose administrations of [18F]-FBA-A20FMDV2 for the PET scanning in period 2. Receives: Drug: GSK3008348; Drug: [18F]-FBA-A20FMDV2
Cohort 1 Placebo	Placebo comparator	Participants will receive a single nebulized dose of placebo during each of 2 planned dosing periods and up to 3 microdose of [18F]-FBA-A20FMDV2 for the PET scanning in period 2. Receives: Drug: Placebo; Drug: [18F]-FBA-A20FMDV2
Cohort 2 GSK3008348	Experimental	Participants will receive a single nebulized dose of GSK3008348 during each of 2 planned dosing periods and up to 3 microdose administrations of [18F]-FBA-A20FMDV2 for the PET scanning in period 2. Receives: Drug: GSK3008348; Drug: [18F]-FBA-A20FMDV2
Cohort 2 Placebo	Placebo comparator	Participants will receive a single nebulized dose of placebo during each of 2 planned dosing periods and up to 3 microdose of [18F]-FBA-A20FMDV2 for the PET scanning in period 2. Receives: Drug: Placebo; Drug: [18F]-FBA-A20FMDV2

What is being measured

The primary outcome is the main question the study is designed to answer.

Period 2: Volume of Distribution (VT) of [18F]-FBA-A20FMDV2 in the Whole Lung (Not Corrected for Air Volume) at 30 Minutes Post-dose Compared to Pre-dose
The change in the uptake of [18F]-FBA-A20FMDV2 in the whole lung, assessed by VT derived from kinetic analysis of the dynamic PET data, was used to evaluate target engagement in the lung after single nebulized doses of GSK3008348. The per-Protocol population consisted of all participants in the Intent-to-Treat population who comply with the protocol and that had at least one evaluable PET measurement post-dose.
Measured: Baseline (pre-dose) and 30 minutes post-dose
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Intent-to-Treat population consisted of all randomized participants who received at least one dose of study treatment.
Measured: Up to 62 days
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, platelet count and WBC count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and WBC Count
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, platelet count and WBC count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 1: Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Hematology Parameter: Hemoglobin
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 1: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Hematology Parameter: Hematocrit
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin
Blood samples were collected to analyze the hematology parameter: mean corpuscle hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin
Blood samples were collected to analyze the hematology parameter: mean corpuscle hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume
Blood samples were collected to analyze the hematology parameter: mean corpuscle volume. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume
Blood samples were collected to analyze the hematology parameter: mean corpuscle volume. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 1: Change From Baseline in Hematology Parameter: Red Blood Cell Count
Blood samples were collected to analyze the hematology parameter: red blood cell count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Hematology Parameter: Red Blood Cell Count
Blood samples were collected to analyze the hematology parameter: red blood cell count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 1: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase
Blood samples were collected to analyze the chemistry parameters: alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase
Blood samples were collected to analyze the chemistry parameters: alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 1: Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 1: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Blood samples were collected to analyze the chemistry parameters: direct bilirubin, total bilirubin and creatinine. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Blood samples were collected to analyze the chemistry parameters: direct bilirubin, total bilirubin and creatinine. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 1: Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen
Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and blood urea nitrogen. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen
Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and blood urea nitrogen. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 1: Number of Participants With Abnormal Urinalysis Results by Dipstick
Urine samples were collected at indicated time points to analyze urinalysis parameters including specific gravity, potential of hydrogen, glucose, protein, blood and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as positive, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Only categories with abnormal urinalysis values are presented.
Measured: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Period 2: Number of Participants With Abnormal Urinalysis Results by Dipstick
Urine samples were collected at indicated time points to analyze urinalysis parameters including specific gravity, potential of hydrogen, glucose, protein, blood and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as positive, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Only categories with abnormal urinalysis values are presented.
Measured: Baseline (Day -1), 24 hours post-GSK3008348 dose and Day 15 (follow-up)
Period 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Vital Signs: DBP and SBP
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)
Period 1: Change From Baseline in Vital Signs: Heart Rate
Heart rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Vital Signs: Heart Rate
Heart rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)
Period 1: Change From Baseline in Vital Sign: Respiration Rate
Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Vital Sign: Respiration Rate
Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)
Period 1: Change From Baseline in Vital Sign: Temperature
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose
Period 2: Change From Baseline in Vital Sign: Temperature
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)
Period 1: Number of Participants With Abnormal Findings for 12-lead Electrocardiograms (ECG) Parameters
Triplicate 12-lead ECG were obtained to measure ECG parameters. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Measured: Pre-dose (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose
Period 2: Number of Participants With Abnormal Findings for 12-lead ECG Parameters
Triplicate 12-lead ECG were obtained to measure ECG parameters. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Measured: Pre-dose (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge), Day 2 (pre-PET scan) and Day 15 (follow-up)
Period 1: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)
FEV1 and FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 and FVC was measured using standard spirometry equipment. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Measured: Baseline (Day -1), 1 hour and 24 hours post-GSK3008348 dose

Secondary outcomes (11)

Period 1: Area Under the Plasma Concentration-time Curve From Zero Hours to Time (AUC[0-t]) After Single Dose Administration of GSK3008348
Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic population consisted of all participants in the Intent-To-Treat population receiving active dose for whom a pharmacokinetic sample was analyzed.
Measured: Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose
Period 2: AUC(0-t) After Single Dose Administration of GSK3008348
Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose
Period 1: Area Under the Plasma Concentration-time Curve From Zero Hours to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3008348
Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose
Period 2: AUC(0-infinity) After Single Dose Administration of GSK3008348
Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose
Period 1: Maximum Observed Plasma Drug Concentration (Cmax) After Single Dose Administration of GSK3008348
Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose
Period 2: Cmax After Single Dose Administration of GSK3008348
Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose
Period 1: Time of Occurrence of Cmax (Tmax) After Single Dose Administration of GSK3008348
Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose
Period 2: Tmax After Single Dose Administration of GSK3008348
Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose
Period 1: Terminal Phase Half-life (t1/2) After Single Dose Administration of GSK3008348
Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose
Period 2: t1/2 After Single Dose Administration of GSK3008348
Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.
Measured: Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose
Period 2: VT of [18F]-FBAA20FMDV2 in the Whole Lung (Not Corrected for Air Volume) Approximately 24 Hours Post-dose Compared to Pre-dose
The changes in the uptake of [18F]-FBA-A20FMDV2 in the whole lung, assessed by VT derived from kinetic analysis of the dynamic PET data was used to evaluate target engagement in the lung after single nebulized doses of GSK3008348
Measured: Baseline (pre-dose) and 24 hours post-dose PET scan 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 201718 Jul 2018

First posted3 Mar 2017
Study start13 Jun 2017
Primary completion4 Jul 2018
Study completion18 Jul 2018

Why it stopped: Sufficient information was gathered from cohort 1 to terminate the study without proceeding to optional cohort 2.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03069989
Sponsor's protocol ID: 204715
Other IDs: 2016-003674-41, 2016
Status last verified: Jun 2019
First submitted: 28 Feb 2017
Last updated: 12 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Single Doses to Evaluate the Safety, Tolerability, Pharmacokinetics and Target Engagement of Nebulised GSK3008348 in Idiopathic Pulmonary Fibrosis Patients, Using Positron Emission Tomography (PET) Imaging
ClinicalTrials.gov ID: NCT03069989
Acronym / sponsor ID: 204715
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Tolerability, IPF, PET imaging, Idiopathic Pulmonary Fibrosis, Safety, Pharmacokinetics, Double-blind
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sufficient information was gathered from cohort 1 to terminate the study without proceeding to optional cohort 2.
Enrolment: 8 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 13 Jun 2017 (actual)
Primary completion: 4 Jul 2018 (actual)
Study completion: 18 Jul 2018 (actual)
First posted: 3 Mar 2017 (actual)
Results: Posted 12 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Cohort 1 GSK3008348	Experimental	Drug: GSK3008348, Drug: [18F]-FBA-A20FMDV2Participants will receive a single nebulized dose of GSK3008348 during each of 2 planned dosing periods and up to 3 microdose administrations of [18F]-FBA-A20FMDV2 for the PET scanning in period 2.
Cohort 1 Placebo	Placebo comparator	Drug: Placebo, Drug: [18F]-FBA-A20FMDV2Participants will receive a single nebulized dose of placebo during each of 2 planned dosing periods and up to 3 microdose of [18F]-FBA-A20FMDV2 for the PET scanning in period 2.
Cohort 2 GSK3008348	Experimental	Drug: GSK3008348, Drug: [18F]-FBA-A20FMDV2Participants will receive a single nebulized dose of GSK3008348 during each of 2 planned dosing periods and up to 3 microdose administrations of [18F]-FBA-A20FMDV2 for the PET scanning in period 2.
Cohort 2 Placebo	Placebo comparator	Drug: Placebo, Drug: [18F]-FBA-A20FMDV2Participants will receive a single nebulized dose of placebo during each of 2 planned dosing periods and up to 3 microdose of [18F]-FBA-A20FMDV2 for the PET scanning in period 2.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male participants aged >= 50 years, and female participants aged >=55 years, at the time of signing the informed consent.
Diagnosis of definite or probable IPF as determined by a responsible and experienced chest physician and based on established criteria defined by the American Thoracic Society/European Respiratory Society Internationale Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias.
Ambulant and capable of attending outpatient visits.
FVC > 50 percent predicted and DLCO > 40 percent predicted.
Body weight >= 45 kilograms (kg) and body mass index (BMI) within the range 18.0-35.0 kg/square meter (inclusive).

Key exclusion criteria (21 listed)

ALT and bilirubin > 1.5x upper limit of normal (ULN; isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35 percent).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT corrected (QTc) > 450 milliseconds (msec), or QTc > 480 msec in participants with Bundle Branch Block.
Current IPF exacerbation, or upper or lower respiratory tract infection on admission to the clinical unit.
History of or suffers from claustrophobia, or unable to lie flat and still on their back for up to 2 hrs in the PET scanner.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK3008348Solution for nebulisation. Available as clear colorless to pale yellow colored solution in a 5mL vial with 20 millimeter (mm) stopper and aluminium seal yellow colored solution in a 5mL vial with 20 millimeter (mm) stopper and aluminium seal.	Drug	Cohort 1 GSK3008348, Cohort 2 GSK3008348
PlaceboSolution for nebulisation. Available as clear colorless to pale yellow colored solution in a 5mL vial with 20mm stopper and aluminium seal.	Drug	Cohort 1 Placebo, Cohort 2 Placebo
[18F]-FBA-A20FMDV2Radio-labeled peptide ligand for PET scan. Available as intravenous (IV) infusion, 20 mL.	Drug	Cohort 1 GSK3008348, Cohort 1 Placebo, Cohort 2 GSK3008348, Cohort 2 Placebo

Primary outcome

Period 2: Volume of Distribution (VT) of [18F]-FBA-A20FMDV2 in the Whole Lung (Not Corrected for Air Volume) at 30 Minutes Post-dose Compared to Pre-dose
Time frame: Baseline (pre-dose) and 30 minutes post-dose
The change in the uptake of [18F]-FBA-A20FMDV2 in the whole lung, assessed by VT derived from kinetic analysis of the dynamic PET data, was used to evaluate target engagement in the lung after single nebulized doses of GSK3008348. The per-Protocol population consisted of all participants in the Intent-to-Treat population who comply with the protocol and that had at least one evaluable PET measurement post-dose.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 62 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Intent-to-Treat population consisted of all randomized participants who received at least one dose of study treatment.
Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, platelet count and WBC count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and WBC Count
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, platelet count and WBC count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Change From Baseline in Hematology Parameter: Hemoglobin
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Hematology Parameter: Hemoglobin
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Change From Baseline in Hematology Parameter: Hematocrit
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Hematology Parameter: Hematocrit
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the hematology parameter: mean corpuscle hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the hematology parameter: mean corpuscle hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the hematology parameter: mean corpuscle volume. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the hematology parameter: mean corpuscle volume. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Change From Baseline in Hematology Parameter: Red Blood Cell Count
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the hematology parameter: red blood cell count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Hematology Parameter: Red Blood Cell Count
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the hematology parameter: red blood cell count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the chemistry parameters: alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the chemistry parameters: alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Chemistry Parameters: Albumin and Total Protein
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the chemistry parameters: direct bilirubin, total bilirubin and creatinine. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the chemistry parameters: direct bilirubin, total bilirubin and creatinine. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and blood urea nitrogen. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and blood urea nitrogen. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Number of Participants With Abnormal Urinalysis Results by Dipstick
Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose
Urine samples were collected at indicated time points to analyze urinalysis parameters including specific gravity, potential of hydrogen, glucose, protein, blood and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as positive, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Only categories with abnormal urinalysis values are presented.
Period 2: Number of Participants With Abnormal Urinalysis Results by Dipstick
Time frame: Baseline (Day -1), 24 hours post-GSK3008348 dose and Day 15 (follow-up)
Urine samples were collected at indicated time points to analyze urinalysis parameters including specific gravity, potential of hydrogen, glucose, protein, blood and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as positive, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Only categories with abnormal urinalysis values are presented.
Period 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Time frame: Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Vital Signs: DBP and SBP
Time frame: Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)
SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Change From Baseline in Vital Signs: Heart Rate
Time frame: Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose
Heart rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Vital Signs: Heart Rate
Time frame: Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)
Heart rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Change From Baseline in Vital Sign: Respiration Rate
Time frame: Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose
Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Vital Sign: Respiration Rate
Time frame: Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)
Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Change From Baseline in Vital Sign: Temperature
Time frame: Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 2: Change From Baseline in Vital Sign: Temperature
Time frame: Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)
Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.
Period 1: Number of Participants With Abnormal Findings for 12-lead Electrocardiograms (ECG) Parameters
Time frame: Pre-dose (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose
Triplicate 12-lead ECG were obtained to measure ECG parameters. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Period 2: Number of Participants With Abnormal Findings for 12-lead ECG Parameters
Time frame: Pre-dose (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge), Day 2 (pre-PET scan) and Day 15 (follow-up)
Triplicate 12-lead ECG were obtained to measure ECG parameters. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Period 1: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)
Time frame: Baseline (Day -1), 1 hour and 24 hours post-GSK3008348 dose
FEV1 and FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 and FVC was measured using standard spirometry equipment. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.

11 secondary outcomes

Period 1: Area Under the Plasma Concentration-time Curve From Zero Hours to Time (AUC[0-t]) After Single Dose Administration of GSK3008348
Time frame: Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose
Period 2: AUC(0-t) After Single Dose Administration of GSK3008348
Time frame: Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose
Period 1: Area Under the Plasma Concentration-time Curve From Zero Hours to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3008348
Time frame: Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose
Period 2: AUC(0-infinity) After Single Dose Administration of GSK3008348
Time frame: Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose
Period 1: Maximum Observed Plasma Drug Concentration (Cmax) After Single Dose Administration of GSK3008348
Time frame: Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose
Period 2: Cmax After Single Dose Administration of GSK3008348
Time frame: Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose
Period 1: Time of Occurrence of Cmax (Tmax) After Single Dose Administration of GSK3008348
Time frame: Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose
Period 2: Tmax After Single Dose Administration of GSK3008348
Time frame: Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose
Period 1: Terminal Phase Half-life (t1/2) After Single Dose Administration of GSK3008348
Time frame: Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose
Period 2: t1/2 After Single Dose Administration of GSK3008348
Time frame: Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose
Period 2: VT of [18F]-FBAA20FMDV2 in the Whole Lung (Not Corrected for Air Volume) Approximately 24 Hours Post-dose Compared to Pre-dose
Time frame: Baseline (pre-dose) and 24 hours post-dose PET scan 2

Results and safety

Results posted to the registry on 12 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	3	3
GSK3008348 1000 mcg	5	5

Primary outcome: Period 2: Volume of Distribution (VT) of [18F]-FBA-A20FMDV2 in the Whole Lung (Not Corrected for Air Volume) at 30 Minutes Post-dose Compared to Pre-dose

Time frame: Baseline (pre-dose) and 30 minutes post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: Milliliter per cubic centimeter(mL/cm^3)

Measure	Placebo n = 2	GSK3008348 1000 mcg n = 5
Baseline	1.664 (19.67)	1.503 (37.32)
30 minutes post-dose PET scan 1	1.572 (8.56)	1.198 (44.37)

Population analysed: Per-Protocol Population. Only those participants with data available at the indicated time points were analyzed.

Primary outcome: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Up to 62 days. Count of participants. Unit: Participants

Measure	Placebo n = 3	GSK3008348 1000 mcg n = 5
AEs	1	3
SAEs	0	0

Population analysed: Intent-to-Treat Population.

Primary outcome: Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count

Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose. Mean (Standard Deviation). Unit: Giga cells per liter

Measure	Placebo n = 3	GSK3008348 1000 mcg n = 5
Basophils	0.000 (0.0000)	-0.008 (0.0179)
Eosinophils	0.000 (0.0000)	0.018 (0.0402)
Lymphocytes	0.267 (0.0577)	-0.086 (0.3361)
Monocytes	-0.033 (0.0577)	-0.106 (0.1232)
Total neutrophils	0.300 (0.5292)	-0.762 (0.8135)
Platelet count	-3.0 (16.46)	-24.2 (11.69)
WBC count	0.467 (0.4933)	-0.982 (0.9509)

Population analysed: Intent-to-Treat Population.

Primary outcome: Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and WBC Count

Time frame: Baseline (Day -1) and 24 hours post-GSK3008348 dose. Mean (Standard Deviation). Unit: Giga cells per liter

Measure	Placebo n = 2	GSK3008348 1000 mcg n = 5
Basophils	0.010 (0.0424)	-0.034 (0.0365)
Eosinophils	0.025 (0.0071)	-0.030 (0.1051)
Lymphocytes	0.485 (0.1061)	0.168 (0.3269)
Monocytes	-0.050 (0.1414)	-0.046 (0.1172)
Total neutrophils	-0.155 (0.5728)	-0.866 (0.6179)
Platelet count	-2.5 (16.26)	15.8 (12.87)
WBC count	0.270 (0.5657)	-0.748 (0.7351)

Population analysed: Intent-to-Treat Population.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs and SAEs were collected from Day 1 up to 62 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
GSK3008348 1000 mcg	0 of 5 (0%)	3 of 5 (60%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK3008348 and [18F]-FBA-A20FMDV2 in people with Idiopathic Pulmonary Fibrosis, run by GlaxoSmithKline at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Period 2: Volume of Distribution (VT) of [18F]-FBA-A20FMDV2 in the Whole Lung (Not Corrected for Air Volume) at 30 Minutes Post-dose Compared to Pre-dose (time frame: Baseline (pre-dose) and 30 minutes post-dose). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03069989.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.