Pulmonary Disease, Chronic ObstructivePhase 1NCT02666287

GSK961081 Alone and With Fluticasone Furoate (FF), Phase 1 (Ph1), Single Dose Regimen (SD), Repeat Dose Regimen (RD), Pharmacokinetic (PK) Study in Healthy Volunteer (HV)

A Phase 1 study testing BAT/FF, BAT and FF in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: BAT/FF, BAT and FF
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteUnited Kingdom
Study dates: 27 Jan 2016to 3 Jun 2016
Phase: Phase 1
Are there results?: None posted in the registry

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 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Between 18 and 64 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body mass index (BMI) within the range 18.5-30.0 kilogram per meter square (kg/m^2) inclusive.
Male or female:
Males: Male subjects with female partners of child bearing potential must use a condom from the time of first dose of study medication until follow-up, or have had a vasectomy with documentation of azoospermia.
Females: A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: Pre-menopausal females with one of the following: documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy, documented bilateral oophorectomy.

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Post-menopausal defined as 12 months of spontaneous amenorrhea, with simultaneous follicle stimulating hormone (FSH) and oestradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) during the trial, and until follow-up. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form as described in this protocol.

Who cannot join

Alanine aminotransferase (ALT) and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Mean QTC > 450 millisecond (msec). NOTES: The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine read or manually over-read.
The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial.
For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the reporting and analysis plan (RAP).
Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or 12-lead ECG.

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Pre-existing condition(s) interfering with normal gastrointestinal (GI) anatomy or motility, including constipation, malabsorption or other GI dysfunction which may interfere with the absorption, distribution, metabolism or elimination of the study drug. Subjects with a history of cholecystectomy must be excluded.
At screening, a supine blood pressure (BP) that is persistently higher (the mean of triplicate measurements taken at least 2 min apart) than 140/90 millimetres of mercury (mmHg).
At screening, a supine mean (triplicate measurements) heart rate (HR) outside the range 40-90 beats per minute (bpm).
Subject is mentally or legally incapacitated.
A history of respiratory disease in the last 10 years.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the first dose of study medication, unless in the opinion of the investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
History of regular alcohol consumption within 6 months of the study, defined as an average weekly intake of >21 units for males and >14 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 milliliter [mL]) of wine or 1 (25 mL) measure of spirits.
Urinary cotinine levels indicative of smoking; current smoker; or ex-smokers who (1) gave up less than 6 months ago or (2) who have a history of more than 10 pack-years. Pack-years is equal to cigarettes per day multiplied to number of years smoked divided by 20.
History of sensitivity to any of the study medications or their components (beta agonist, anti-muscarinic, corticosteroid medication, magnesium stearate, or lactose), or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicated the subject's participation.
Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months before the first dose of study treatment.
A positive test for human immunodeficiency virus (HIV).
A positive pre-study drug/alcohol screen.
The subject has participated in a clinical trial and has received an investigational product (IP) within 3 months before their first dose in the current study.
Exposure to more than four new chemical entities within 12 months before the subject's first dose.
Unable to refrain from consumption of red wine, Seville oranges, grapefruit or grapefruit juice from 7 days before the first dose of study medication until the follow-up visit.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 90 day period.
Unwillingness or inability to follow the procedures outlined in the protocol.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
London, NW10 7EW

Other trials in United Kingdom

About this study

Official title: An Open Label, Six-period Cross-over, Single and Repeat Dose Study to Determine the Pharmacokinetics of Fluticasone Furoate and GSK961081 When Administered Alone, in Combination, or Concurrently Via the ELLIPTA

Batefenterol (BAT) is a novel bifunctional molecule that combines muscarinic antagonism and beta2-agonism in a single molecule and is in development for the treatment of chronic obstructive pulmonary disease (COPD). FF is a corticosteroid approved as the inhaled corticosteroid (ICS) component of a combination product, with vilanterol (VI), a long-acting beta2-agonist for COPD. In the current study FF will be investigated as an inhaled product in combination with BAT, for treatment of COPD.

This study is an open-label, six-way crossover, single and repeat dose study to evaluate the systemic pharmacokinetics, safety and tolerability of FF and BAT when administered via the ELLIPTA™ alone, in combination, or concurrently at 3 times the clinical dose, following a single dose, and at the proposed clinical dose, following repeat doses.

This study will consist of screening period, 6 treatment periods, and a follow-up visit. Each subject will have 3 periods in which they receive a single dose treatment regimen (3 inhalations on Day 1 of each single dose study period) and 3 periods in which they receive a single dose treatment regimen followed by a 7-day, once-daily, repeated dose. On Day 1 of those periods, subjects will receive their single dose as 3 inhalations. On Days 2-8, subjects will receive 1 inhalation per day for the repeated dose regimen. There will be a minimum of 7-day washout between each treatment periods. All subjects will receive 9 treatments and follow-up procedures will be done 7 14 days after the last dose.

Forty eight healthy subjects will be enrolled into the study, such that approximately 40 subjects complete dosing and PK assessments. The total duration of participation for each subject in this study will be up to 15 weeks. ELLIPTA is a registered trademark of the GlaxoSmithKline [GSK] group of companies.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: BAT/FF, BAT, FF, FF (MgSt), FF/Vilanterol
Keywords: Fluticasone furoate, Chronic obstructive pulmonary disease, Batefenterol, Dry Powder Inhaler, Respiratory, Pharmacokinetics, Ellipta, Healthy Subjects
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

BAT/FFDrug
BAT/FF is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 300 mcg per blister of BAT blended with lactose and its physical appearance is dry white powder. Second strip contains 100 mcg per blister of FF blended with lactose and its physical appearance is dry white powder.
BATDrug
BAT is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 300 mcg per blister of BAT blended with lactose appear as dry white powder. Second strip contains lactose which appear as a dry white powder.
FFDrug
FF is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 100 mcg per blister of FF blended with lactose appear as dry white powder and second strip contains lactose which appear as dry white powder.
FF (MgSt)Drug
FF magnesium stearate is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 100 mcg per blister of FF blended with lactose appear as dry white powder and second strip contains lactose with magnesium stearate which appear as dry white powder.
FF/VilanterolDrug
FF/Vilanterol is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 25 mcg per blister of vilanterol blended with lactose and magnesium stearate appear as dry white powder and second strip contains 100 mcg per blister of FF blended with lactose which appear as dry white powder.

Study groups in NCT02666287
Study group	Role	What they receive
Sequence 1	Experimental	Each subject will receive all the 9 treatment regimens in the following order: A,G/B/F/C,H/E/D,I with a washout period of 7 days between each treatment period administered via the ELLIPTA inhaler. Where Treatment A= BAT/FF 900/300 microgram (mcg) (3 inhalations of 300/100 mcg). Treatment B= BAT 900 mcg (3 inhalations of 300 mcg) concurrently with FF (lactose) 300 mcg (3 inhalations of 100 mcg) from separate inhalers. Treatment C= BAT 900 mcg (3 inhalations of 300 mcg). Treatment D= FF (lactose) 300 mcg (3 inhalations of 100 mcg). Treatment E= FF (magnesium stearate [MgSt]) 300 mcg (3 inhalations of 100 mcg). Treatment F= FF/VI 300/75 mcg (3 inhalations of 100 mcg/25 mcg). Treatment G= 7-day repeat doses: BAT/FF 300/100 mcg (1 inhalation). Treatment H= 7-day repeat doses: BAT 300 mcg (1 inhalation). Treatment I= 7-day repeat doses: FF (lactose) 100 mcg (1 inhalation). Receives: Drug: BAT/FF; Drug: BAT; Drug: FF; Drug: FF (MgSt); Drug: FF/Vilanterol
Sequence 2	Experimental	Each subject will receive all the 9 treatment regimens in the following order: B/C,H/A,G/D,I/F/E with a washout period of 7 days between each treatment period. Receives: Drug: BAT/FF; Drug: BAT; Drug: FF; Drug: FF (MgSt); Drug: FF/Vilanterol
Sequence 3	Experimental	Each subject will receive all the 9 treatment regimens in the following order: C,H/D,I/B/E/A,G/F with a washout period of 7 days between each treatment period. Receives: Drug: BAT/FF; Drug: BAT; Drug: FF; Drug: FF (MgSt); Drug: FF/Vilanterol
Sequence 4	Experimental	Each subject will receive all the 9 treatment regimens in the following order: D,I/E/C,H/F/B/A,G with a washout period of 7 days between each treatment period. Receives: Drug: BAT/FF; Drug: BAT; Drug: FF; Drug: FF (MgSt); Drug: FF/Vilanterol
Sequence 5	Experimental	Each subject will receive all the 9 treatment regimens in the following order: E/F/D,I/A,G/C,H/B with a washout period of 7 days between each treatment period. Receives: Drug: BAT/FF; Drug: BAT; Drug: FF; Drug: FF (MgSt); Drug: FF/Vilanterol
Sequence 6	Experimental	Each subject will receive all the 9 treatment regimens in the following order: F/A,G/E/B/D,I/C,H with a washout period of 7 days between each treatment period. Receives: Drug: BAT/FF; Drug: BAT; Drug: FF; Drug: FF (MgSt); Drug: FF/Vilanterol

What is being measured

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

Area under the plasma concentration-time curve (AUC) of FF in plasma on Day 7 of repeat dosing
The following PK parameter will be measured: AUC
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen
Maximum observed plasma concentration (Cmax) of FF in plasma on Day 7 of repeat dosing
The following PK parameter will be measured: Cmax
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen

Secondary outcomes (15)

AUC of BAT in plasma on Day 7 of repeat dosing
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen
Cmax of BAT in plasma on Day 7 of repeat dosing
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen
AUC of FF in plasma on Day 1 of study period
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 1 of each treatment period
Cmax of FF in plasma on Day 1 of study period
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 1 of each treatment period
AUC of BAT in plasma on Day 1 of study period
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 1 of each treatment period
Cmax of BAT in plasma on Day 1 of study period
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 1 of each treatment period
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to 15 weeks
Safety as assessed by 12-lead Electrocardiogram (ECG)
A single 12-lead ECG will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) intervals.
Measured: Up to 15 weeks
Safety as assessed by systolic and diastolic blood pressure measurements
Three readings of systolic and diastolic pressure will be taken at screening and Day -1. Single measurements will be taken at all other specified timepoints
Measured: Up to 15 weeks
Safety as assessed by oral temperature measurements
Oral temperature measurements will be recorded at pre-dose on dosing days
Measured: Up to 15 weeks
Safety as assessed by heart rate measurements
Three readings of heart rate will be taken at screening and Day -1. Single measurements will be taken at all other timepoints
Measured: Up to 15 weeks
Safety as assessed by respiratory rate measurements
Respiratory rate measurements will be recorded at pre-dose on dosing days
Measured: Up to 15 weeks
Composite of Haematology parameters as a measure of safety
The following hematology parameters will be measured: Platelet Count, red blood cell (RBC) count, Hemoglobin, Hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), white blood cell (WBC) count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils
Measured: Up to 15 weeks
Composite of Clinical Chemistry parameters as a measure of safety
The following clinical chemistry parameters will be measured: Urea, Creatinine, Glucose (fasting), Uric acid, Potassium, Sodium, Calcium, Chloride, Phosphate, Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase, Gamma-glutamyl transferase (GGT), Cholesterol, Triglycerides, Total Bilirubin, Total Protein, Albumin, and Globulin.
Measured: Up to 15 weeks
Composite of Urinalysis parameters as a measure of safety
The following urinalysis parameters will be measured by dip stick test: protein, blood, ketones, glucose, bilirubin, urobilinogen, leukocyte esterase, specific gravity, nitrites, power of hydrogen (pH). If urine dipstick is abnormal for leukocyte esterase, nitrites, blood or protein, microscopic examination will be performed.
Measured: Up to 15 weeks

Timeline

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

27 Jan 20163 Jun 2016

First posted28 Jan 2016 (estimated)
Study start27 Jan 2016
Primary completion3 Jun 2016
Study completion3 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02666287
Sponsor's protocol ID: 201958
Status last verified: May 2017
First submitted: 25 Jan 2016
Last updated: 15 May 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ambery C, Young G, Fuller T, Georgiou A, Ramsay D, Puri A, Daley-Yates P. Open-Label, Crossover Study to Determine the Pharmacokinetics of Fluticasone Furoate and Batefenterol When Administered Alone, in Combination, or Concurrently. Clin Pharmacol Drug Dev. 2019 Feb;8(2):188-197. doi: 10.1002/cpdd.603. Epub 2018 Aug 2.
PubMed 30070770

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 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Six-period Cross-over, Single and Repeat Dose Study to Determine the Pharmacokinetics of Fluticasone Furoate and GSK961081 When Administered Alone, in Combination, or Concurrently Via the ELLIPTA
ClinicalTrials.gov ID: NCT02666287
Acronym / sponsor ID: 201958
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Fluticasone furoate, Chronic obstructive pulmonary disease, Batefenterol, Dry Powder Inhaler, Respiratory, Pharmacokinetics, Ellipta, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Hammersmith Medicines Research
Study start: 27 Jan 2016 (actual)
Primary completion: 3 Jun 2016 (actual)
Study completion: 3 Jun 2016 (actual)
First posted: 28 Jan 2016 (estimated)
Results: Not posted in the source record

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: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1	Experimental	Drug: BAT/FF, Drug: BAT, Drug: FF, Drug: FF (MgSt), Drug: FF/VilanterolEach subject will receive all the 9 treatment regimens in the following order: A,G/B/F/C,H/E/D,I with a washout period of 7 days between each treatment period administered via the ELLIPTA inhaler. Where Treatment A= BAT/FF 900/300 microgram (mcg) (3 inhalations of 300/100 mcg). Treatment B= BAT 900 mcg (3 inhalations of 300 mcg) concurrently with FF (lactose) 300 mcg (3 inhalations of 100 mcg) from separate inhalers. Treatment C= BAT 900 mcg (3 inhalations of 300 mcg). Treatment D= FF (lactose) 300 mcg (3 inhalations of 100 mcg). Treatment E= FF (magnesium stearate [MgSt]) 300 mcg (3 inhalations of 100 mcg). Treatment F= FF/VI 300/75 mcg (3 inhalations of 100 mcg/25 mcg). Treatment G= 7-day repeat doses: BAT/FF 300/100 mcg (1 inhalation). Treatment H= 7-day repeat doses: BAT 300 mcg (1 inhalation). Treatment I= 7-day repeat doses: FF (lactose) 100 mcg (1 inhalation).
Sequence 2	Experimental	Drug: BAT/FF, Drug: BAT, Drug: FF, Drug: FF (MgSt), Drug: FF/VilanterolEach subject will receive all the 9 treatment regimens in the following order: B/C,H/A,G/D,I/F/E with a washout period of 7 days between each treatment period.
Sequence 3	Experimental	Drug: BAT/FF, Drug: BAT, Drug: FF, Drug: FF (MgSt), Drug: FF/VilanterolEach subject will receive all the 9 treatment regimens in the following order: C,H/D,I/B/E/A,G/F with a washout period of 7 days between each treatment period.
Sequence 4	Experimental	Drug: BAT/FF, Drug: BAT, Drug: FF, Drug: FF (MgSt), Drug: FF/VilanterolEach subject will receive all the 9 treatment regimens in the following order: D,I/E/C,H/F/B/A,G with a washout period of 7 days between each treatment period.
Sequence 5	Experimental	Drug: BAT/FF, Drug: BAT, Drug: FF, Drug: FF (MgSt), Drug: FF/VilanterolEach subject will receive all the 9 treatment regimens in the following order: E/F/D,I/A,G/C,H/B with a washout period of 7 days between each treatment period.
Sequence 6	Experimental	Drug: BAT/FF, Drug: BAT, Drug: FF, Drug: FF (MgSt), Drug: FF/VilanterolEach subject will receive all the 9 treatment regimens in the following order: F/A,G/E/B/D,I/C,H with a washout period of 7 days between each treatment period.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Between 18 and 64 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, vital signs, laboratory tests, and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator agrees and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body mass index (BMI) within the range 18.5-30.0 kilogram per meter square (kg/m^2) inclusive.
Male or female:
Males: Male subjects with female partners of child bearing potential must use a condom from the time of first dose of study medication until follow-up, or have had a vasectomy with documentation of azoospermia.

Key exclusion criteria (23 listed)

Alanine aminotransferase (ALT) and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Mean QTC > 450 millisecond (msec). NOTES: The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine read or manually over-read.
The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial.
For purposes of data analysis, QTcB, QTcF, another QT correction formula, or a composite of available values of QTc will be used as specified in the reporting and analysis plan (RAP).

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
BAT/FFBAT/FF is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 300 mcg per blister of BAT blended with lactose and its physical appearance is dry white powder. Second strip contains 100 mcg per blister of FF blended with lactose and its physical appearance is dry white powder.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
BATBAT is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 300 mcg per blister of BAT blended with lactose appear as dry white powder. Second strip contains lactose which appear as a dry white powder.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
FFFF is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 100 mcg per blister of FF blended with lactose appear as dry white powder and second strip contains lactose which appear as dry white powder.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
FF (MgSt)FF magnesium stearate is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 100 mcg per blister of FF blended with lactose appear as dry white powder and second strip contains lactose with magnesium stearate which appear as dry white powder.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
FF/VilanterolFF/Vilanterol is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 25 mcg per blister of vilanterol blended with lactose and magnesium stearate appear as dry white powder and second strip contains 100 mcg per blister of FF blended with lactose which appear as dry white powder.	Drug	Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6

Primary outcome

Area under the plasma concentration-time curve (AUC) of FF in plasma on Day 7 of repeat dosing
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen
The following PK parameter will be measured: AUC
Maximum observed plasma concentration (Cmax) of FF in plasma on Day 7 of repeat dosing
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen
The following PK parameter will be measured: Cmax

15 secondary outcomes

AUC of BAT in plasma on Day 7 of repeat dosing
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen
Cmax of BAT in plasma on Day 7 of repeat dosing
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen
AUC of FF in plasma on Day 1 of study period
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 1 of each treatment period
Cmax of FF in plasma on Day 1 of study period
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 1 of each treatment period
AUC of BAT in plasma on Day 1 of study period
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 1 of each treatment period
Cmax of BAT in plasma on Day 1 of study period
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 1 of each treatment period
Number of participants with adverse events (AEs)
Time frame: Up to 15 weeks
Safety as assessed by 12-lead Electrocardiogram (ECG)
Time frame: Up to 15 weeks
Safety as assessed by systolic and diastolic blood pressure measurements
Time frame: Up to 15 weeks
Safety as assessed by oral temperature measurements
Time frame: Up to 15 weeks
Safety as assessed by heart rate measurements
Time frame: Up to 15 weeks
Safety as assessed by respiratory rate measurements
Time frame: Up to 15 weeks
Composite of Haematology parameters as a measure of safety
Time frame: Up to 15 weeks
Composite of Clinical Chemistry parameters as a measure of safety
Time frame: Up to 15 weeks
Composite of Urinalysis parameters as a measure of safety
Time frame: Up to 15 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
Derived from this study: PubMed 30070770Ambery C, Young G, Fuller T, Georgiou A, Ramsay D, Puri A, Daley-Yates P. Open-Label, Crossover Study to Determine the Pharmacokinetics of Fluticasone Furoate and Batefenterol When Administered Alone, in Combination, or Concurrently. Clin Pharmacol Drug Dev. 2019 Feb;8(2):188-197. doi: 10.1002/cpdd.603. Epub 2018 Aug 2.
Results for study 201958 can be found on the GSK Clinical Study Register.Link provided by the sponsor.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAT/FF, BAT and FF in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site 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 23 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: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Area under the plasma concentration-time curve (AUC) of FF in plasma on Day 7 of repeat dosing (time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dosing on Day 7 of each repeat dose regimen). The study lists 2 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 NCT02666287, which also lists 1 linked publication.

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 15 May 2017.