Heart Failure, CongestivePhase 1NCT02925546

A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets

A Phase 1 study testing GSK2798745 Micronized API without SLS and hypermellose (Tablet A), GSK2798745 Micronized API with SLS and hypermellose (Tablet B) and GSK2798745 milled API without SLS and hypermellose (Tablet C) in people with Heart Failure, Congestive, run by GlaxoSmithKline at 1 site in United States.

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 75 yearsHealthy volunteers can take part
Conditions the study is for: Heart Failure, Congestive
What is being tested?: GSK2798745 Micronized API without SLS and hypermellose (Tablet A), GSK2798745 Micronized API with SLS and hypermellose (Tablet B) and GSK2798745 milled API without SLS and hypermellose (Tablet C)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Oct 2016to Dec 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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Between 18 and 75 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, 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 in consultation with the Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
Body weight >=50 kg and body mass index within the range 18 - 32 kilogram (kg)/meter (m)^2 (inclusive)
Male or female of non-child bearing potential:
A male subject with a female partner of child bearing potential is eligible to participate if he agrees to use contraception as mentioned in the protocol during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period A female subject is eligible to participate if she is 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 consent form and in this protocol

Who cannot join

History of acute coronary syndromes including unstable angina or myocardial infarction within 6 months of screening
History of stroke or seizure disorder within 5 years of Screening
Active ulcer disease or gastrointestinal bleeding at the time of screening
Alanine transaminase (ALT) and bilirubin >1.5x Upper limit of normal (ULN) 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)
QT interval corrected according to Fridericia's formula (QTcF) >450 milliseconds (msec)

Show all 18Show fewer

History or current evidence of any serious or clinically significant gastrointestinal, renal, endocrine, neurologic, hematologic or other condition that is uncontrolled on permitted therapies or that would, in the opinion of the investigator or the Medical Monitor, make the subject unsuitable for inclusion in this study
Urinary cotinine levels indicative of current smoking or regular use of tobacco- or nicotine-containing products at time of screening (cotinine levels >200 nanogram [ng]/millimeter [mL])
History of alcohol abuse within 6 months of the study based on the following criteria:
An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
Presence of hepatitis B surface antigen, positive hepatitis C antibody test result at screening or within 3 months of screening.
A positive test for human immunodeficiency virus antibody
A positive pre-study drug/alcohol screen
A screening cardiac Troponin level > ULN
Use of another investigational product in a clinical study within the following time period prior to the first administration of study medication 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 investigational medicinal products within 12 months prior to the first administration of study medication.
Unable to refrain from the use of prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) except permitted medications listed in the protocol, within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication until completion of the follow-up visit, unless in the opinion of the Investigator and/ or sponsor the medication will not interfere with the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Overland Park, Kansas, 66211

Other trials in United States

About this study

Official title: An Open Label, Randomized, Single Dose, Crossover Study to Determine the Pharmacokinetics of Three Tablet Formulations of GSK2798745 in Healthy Subjects

GSK2798745 is being developed as a novel therapeutic intervention for the treatment of pulmonary edema associated with heart failure (HF) and is currently under investigation in the form of a compounded capsule. This is an open-label, randomized, single-dose, crossover study with the purpose to determine the pharmacokinetics (PK) of three 2.4 milligrams (mg) tablet formulations of GSK2798745 in 12 healthy subjects. The three formulations developed for this study will be micronized GSK2798745 active pharmaceutical ingredient (API) (Tablet A), micronized GSK2798745 API with sodium lauryl sulfate (SLS) and hypromellose (Tablet B), milled GSK2798745 API with SLS and hypermellose (Tablet C), and Tablet D, which will be either A/B/C based on interim PK analysis of data from the first three treatment periods.

Following a 30-day screening period, subjects will be randomized to one of the 6 treatment sequences: Treatment sequence 1: ABCD, 2=CABD, 3=ACBD, 4=BACD, 5=BCAD, 6=CBAD over three 4-day treatment periods. For treatment period 4, the best formulation based on the interim analysis data from the three treatment periods will be evaluated under fed conditions. Each treatment period will be separated by a minimum of 7 (+14)-day washout period. The total duration of participation in the study will be approximately 11 weeks including the follow-up visit.

Conditions: Heart Failure, Congestive
Being tested: GSK2798745 Micronized API without SLS and hypermellose (Tablet A), GSK2798745 Micronized API with SLS and hypermellose (Tablet B), GSK2798745 milled API without SLS and hypermellose (Tablet C)
Keywords: Healthy, Pharmacokinetics, Phase I, GSK2798745, Tablet
Medical subject headings: Heart Failure

What participants receive

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

GSK2798745 Micronized API without SLS and hypermellose (Tablet A)Drug
This is an immediate release tablet containing 2.4 mg of micronized GSK2798745 API; to be administered orally with 240 mL of water under fasted/fed conditions
GSK2798745 Micronized API with SLS and hypermellose (Tablet B)Drug
This is an immediate release tablet containing 2.4 mg of micronized GSK2798745 API with SLS and hypermellose; to be administered orally in fasted/fed conditions with 240 mL of water
GSK2798745 milled API without SLS and hypermellose (Tablet C)Drug
This is an immediate release tablet containing 2.4 mg of milled GSK2798745 API with SLS and hypermellose; to be administered orally in fasted/fed conditions, with 240 mL of water

Study groups in NCT02925546
Study group	Role	What they receive
GSK2798745 ABCD treatment sequence	Experimental	Subjects will be given 2.4 mg single oral doses of GSK2798745 (micronized API without SLS and hypromellose) in fasted state (treatment A), 2.4 mg of GSK2798745 (micronized API with SLS and hypromellose) in fasted state (treatment B), GSK2798745 (milled API with SLS and hypromellose) in fasted state (treatment C), and GSK2798745 tablet in fed state (treatment D) in either treatment periods 1, 2, or 3; the three treatment periods will each be separated by a minimum washout period of 7 days Receives: Drug: GSK2798745 Micronized API without SLS and hypermellose (Tablet A); Drug: GSK2798745 Micronized API with SLS and hypermellose (Tablet B); Drug: GSK2798745 milled API without SLS and hypermellose (Tablet C)
GSK2798745 CABD treatment sequence	Experimental	Subjects will be given 2.4 mg GSK2798745 (milled API with SLS and hypromellose) in fasted state (treatment C), 2.4 mg single oral doses of GSK2798745 (micronized API without SLS and hypromellose) in fasted state (treatment A), 2.4 mg of GSK2798745 (micronized API with SLS and hypromellose) in fasted state (treatment B), and GSK2798745 tablet in fed state (treatment D) in either treatment periods 1, 2, or 3; the three treatment periods will each be separated by a minimum washout period of 7 days Receives: Drug: GSK2798745 Micronized API without SLS and hypermellose (Tablet A); Drug: GSK2798745 Micronized API with SLS and hypermellose (Tablet B); Drug: GSK2798745 milled API without SLS and hypermellose (Tablet C)
GSK2798745 ACBD treatment sequence	Experimental	Subjects will be given 2.4 mg single oral doses of GSK2798745 (micronized API without SLS and hypromellose) in fasted state (treatment A), 2.4 mg GSK2798745 (milled API with SLS and hypromellose) in fasted state (treatment C), 2.4 mg of GSK2798745 (micronized API with SLS and hypromellose) in fasted state (treatment B), and GSK2798745 tablet in fed state (treatment D) in either treatment periods 1, 2, or 3; the three treatment periods will each be separated by a minimum washout period of 7 days Receives: Drug: GSK2798745 Micronized API without SLS and hypermellose (Tablet A); Drug: GSK2798745 Micronized API with SLS and hypermellose (Tablet B); Drug: GSK2798745 milled API without SLS and hypermellose (Tablet C)
GSK2798745 BACD treatment sequence	Experimental	Subjects will be given 2.4 mg of GSK2798745 (micronized API with SLS and hypromellose) in fasted state (treatment B), 2.4 mg of GSK2798745 (micronized API without SLS and hypromellose) in fasted state (treatment A), 2.4 mg GSK2798745 (milled API with SLS and hypromellose) in fasted state (treatment C), and GSK2798745 tablet in fed state (treatment D) in either treatment periods 1, 2, or 3; the three treatment periods will each be separated by a minimum washout period of 7 days Receives: Drug: GSK2798745 Micronized API without SLS and hypermellose (Tablet A); Drug: GSK2798745 Micronized API with SLS and hypermellose (Tablet B); Drug: GSK2798745 milled API without SLS and hypermellose (Tablet C)
GSK2798745 BCAD treatment sequence	Experimental	Subjects will be given 2.4 mg of GSK2798745 (micronized API with SLS and hypromellose) in fasted state (treatment B), 2.4 mg GSK2798745 (milled API with SLS and hypromellose) in fasted state (treatment C), 2.4 mg single oral doses of GSK2798745 (micronized API without SLS and hypromellose) in fasted state (treatment A), and GSK2798745 tablet in fed state (treatment D) in either treatment periods 1, 2, or 3; the three treatment periods will each be separated by a minimum washout period of 7 days Receives: Drug: GSK2798745 Micronized API without SLS and hypermellose (Tablet A); Drug: GSK2798745 Micronized API with SLS and hypermellose (Tablet B); Drug: GSK2798745 milled API without SLS and hypermellose (Tablet C)
GSK2798745 CBAD treatment sequence	Experimental	Subjects will be given 2.4 mg GSK2798745 (milled API with SLS and hypromellose) in fasted state (treatment C), 2.4 mg of GSK2798745 (micronized API with SLS and hypromellose) in fasted state (treatment B), 2.4 mg single oral doses of GSK2798745 (micronized API without SLS and hypromellose) in fasted state (treatment A), and GSK2798745 tablet in fed state (treatment D) in either treatment periods 1, 2, or 3; the three treatment periods will each be separated by a minimum washout period of 7 days Receives: Drug: GSK2798745 Micronized API without SLS and hypermellose (Tablet A); Drug: GSK2798745 Micronized API with SLS and hypermellose (Tablet B); Drug: GSK2798745 milled API without SLS and hypermellose (Tablet C)

What is being measured

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

Area under the curve (AUC) of GSK2798745
AUC will be determined following a single oral dose of GSK2798745 under fasted conditions (Treatment periods 1-3) and fed conditions (Treatment period 4)
Measured: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in each of the treatment periods
Maximum plasma concentration (Cmax) of GSK2798745
Cmax will be determined following a single oral dose of GSK2798745 under fasted conditions (Treatment periods 1-3) and fed conditions (Treatment period 4)
Measured: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in each of the treatment periods

Secondary outcomes (16)

Time to maximum observed concentration (Tmax) of GSK2798745
Tmax will be determined following a single oral dose of GSK2798745
Measured: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in each of the treatment periods
Elimination half-life (T1/2) of GSK2798745
T1/2 will be determined following a single oral dose of GSK2798745
Measured: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in each of the treatment periods
AUC of GSK2798745 following a standard Food Drug Administration (FDA) high fat, high calorie meal
The effect of food on the PK of one of the three tablet formulations of GSK2798745 will be assessed by AUC following a single oral dose of GSK2798745 which was admininstered 30 minutes after start of a FDA high fat, high-calorie meal
Measured: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in treatment period 4
Cmax of GSK2798745 following a standard FDA high fat, high calorie meal
The effect of food on the pharmacokinetics of one of the three tablet formulations of GSK2798745 will be assessed by Cmax following a single oral dose of GSK2798745 which was admininstered 30 minutes after start of a FDA high fat, high-calorie meal
Measured: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in treatment period 4
Systolic and diastolic blood pressure as a measure of safety and tolerability of GSK2798745
This will be measured in triplicate in a semi-supine position after 5 minutes rest
Measured: Up to 11 weeks
Pulse rate as a measure of safety and tolerability of GSK2798745
This will be measured in triplicate in a semi-supine position after 5 minutes rest
Measured: Up to 11 weeks
Respiratory rate as a measure of safety and tolerability of GSK2798745
This will be measured in triplicate in a semi-supine position after 5 minutes rest
Measured: Up to 11 weeks
Safety and tolerability of single dose of GSK2798745 as assessed by electorcardiograms (ECGs)
Triplicate twelve-lead ECGs will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected according to Fridericia's formula (QTcF) intervals. ECGs will be measured after resting in semi-supine position for 5 minutes
Measured: Up to 11 weeks
Safety and tolerability of single dose of GSK2798745 as assessed by hematology
Hematology parameters include platelet, red blood cell counts, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils, and basophils
Measured: At Baseline (Day -1)
Safety and tolerability of single dose of GSK2798745 as assessed by clinical chemistry
Clinical chemistry parameters included Blood urea nitrogen, Creatinine, Glucose (fasting), Uric acid, Potassium, Sodium, Calcium, Chloride, Total Protein, Albumin, and creatine phosphokinase
Measured: At Baseline (Day -1)
Safety and tolerability of single dose of GSK2798745 as assessed by urinalysis
The following urinalysis parameters will be measured: Protein, Blood, Ketones, glucose, specific gravity, power of hydrogen (pH) by dipstick method. If blood or protein is abnormal, microscopic examination will be performed
Measured: At Baseline (Day -1)
Safety and tolerability of single dose of GSK2798745 as assessed by liver function tests (LFTs)
The following parameters will be measured: Aspartate aminotransferase, Alanine aminotransferase, Alkaline phosphatase, Total and direct bilirubin
Measured: At Baseline (Day -1)
Safety and tolerability of single dose of GSK2798745 as assessed by weight assessments
Measured: Up to 11 weeks
Safety and tolerability of single dose of GSK2798745 as assessed by appetite assessments
Subject will be administered a four-item Simplified Nutritional Assessment Questionnaire (SNAQ) on Days -1 and 2 of each treatment period and at the Follow Up Visit; the sum of the scores for the individual items will constitute the SNAQ
Measured: Up to 11 weeks
Safety and tolerability of single dose of GSK2798745 as assessed by troponin measurement
Measured: At Baseline (Day -1) and 24 hours post dose on Day 2
Number of subjects with any adverse events (AEs) as a measure of safety and tolerability of GSK2798745
An AE is any untoward medical occurrence in a subject 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 11 weeks

Timeline

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

Oct 2016Dec 2016

First posted6 Oct 2016 (estimated)
Study startOct 2016
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Heart Failure, CongestiveStudies 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: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02925546
Sponsor's protocol ID: 204725
Status last verified: Jan 2017
First submitted: 4 Oct 2016
Last updated: 25 Jan 2017
Results posted: No
Data monitoring committee: 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?

See locations

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RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
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All Heart Failure, Congestive trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Randomized, Single Dose, Crossover Study to Determine the Pharmacokinetics of Three Tablet Formulations of GSK2798745 in Healthy Subjects
ClinicalTrials.gov ID: NCT02925546
Acronym / sponsor ID: 204725
Conditions: Heart Failure, Congestive
Keywords: Healthy, Pharmacokinetics, Phase I, GSK2798745, Tablet
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Oct 2016
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 6 Oct 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: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
GSK2798745 ABCD treatment sequence	Experimental	Drug: GSK2798745 Micronized API without SLS and hypermellose (Tablet A), Drug: GSK2798745 Micronized API with SLS and hypermellose (Tablet B), Drug: GSK2798745 milled API without SLS and hypermellose (Tablet C)Subjects will be given 2.4 mg single oral doses of GSK2798745 (micronized API without SLS and hypromellose) in fasted state (treatment A), 2.4 mg of GSK2798745 (micronized API with SLS and hypromellose) in fasted state (treatment B), GSK2798745 (milled API with SLS and hypromellose) in fasted state (treatment C), and GSK2798745 tablet in fed state (treatment D) in either treatment periods 1, 2, or 3; the three treatment periods will each be separated by a minimum washout period of 7 days
GSK2798745 CABD treatment sequence	Experimental	Drug: GSK2798745 Micronized API without SLS and hypermellose (Tablet A), Drug: GSK2798745 Micronized API with SLS and hypermellose (Tablet B), Drug: GSK2798745 milled API without SLS and hypermellose (Tablet C)Subjects will be given 2.4 mg GSK2798745 (milled API with SLS and hypromellose) in fasted state (treatment C), 2.4 mg single oral doses of GSK2798745 (micronized API without SLS and hypromellose) in fasted state (treatment A), 2.4 mg of GSK2798745 (micronized API with SLS and hypromellose) in fasted state (treatment B), and GSK2798745 tablet in fed state (treatment D) in either treatment periods 1, 2, or 3; the three treatment periods will each be separated by a minimum washout period of 7 days
GSK2798745 ACBD treatment sequence	Experimental	Drug: GSK2798745 Micronized API without SLS and hypermellose (Tablet A), Drug: GSK2798745 Micronized API with SLS and hypermellose (Tablet B), Drug: GSK2798745 milled API without SLS and hypermellose (Tablet C)Subjects will be given 2.4 mg single oral doses of GSK2798745 (micronized API without SLS and hypromellose) in fasted state (treatment A), 2.4 mg GSK2798745 (milled API with SLS and hypromellose) in fasted state (treatment C), 2.4 mg of GSK2798745 (micronized API with SLS and hypromellose) in fasted state (treatment B), and GSK2798745 tablet in fed state (treatment D) in either treatment periods 1, 2, or 3; the three treatment periods will each be separated by a minimum washout period of 7 days
GSK2798745 BACD treatment sequence	Experimental	Drug: GSK2798745 Micronized API without SLS and hypermellose (Tablet A), Drug: GSK2798745 Micronized API with SLS and hypermellose (Tablet B), Drug: GSK2798745 milled API without SLS and hypermellose (Tablet C)Subjects will be given 2.4 mg of GSK2798745 (micronized API with SLS and hypromellose) in fasted state (treatment B), 2.4 mg of GSK2798745 (micronized API without SLS and hypromellose) in fasted state (treatment A), 2.4 mg GSK2798745 (milled API with SLS and hypromellose) in fasted state (treatment C), and GSK2798745 tablet in fed state (treatment D) in either treatment periods 1, 2, or 3; the three treatment periods will each be separated by a minimum washout period of 7 days
GSK2798745 BCAD treatment sequence	Experimental	Drug: GSK2798745 Micronized API without SLS and hypermellose (Tablet A), Drug: GSK2798745 Micronized API with SLS and hypermellose (Tablet B), Drug: GSK2798745 milled API without SLS and hypermellose (Tablet C)Subjects will be given 2.4 mg of GSK2798745 (micronized API with SLS and hypromellose) in fasted state (treatment B), 2.4 mg GSK2798745 (milled API with SLS and hypromellose) in fasted state (treatment C), 2.4 mg single oral doses of GSK2798745 (micronized API without SLS and hypromellose) in fasted state (treatment A), and GSK2798745 tablet in fed state (treatment D) in either treatment periods 1, 2, or 3; the three treatment periods will each be separated by a minimum washout period of 7 days
GSK2798745 CBAD treatment sequence	Experimental	Drug: GSK2798745 Micronized API without SLS and hypermellose (Tablet A), Drug: GSK2798745 Micronized API with SLS and hypermellose (Tablet B), Drug: GSK2798745 milled API without SLS and hypermellose (Tablet C)Subjects will be given 2.4 mg GSK2798745 (milled API with SLS and hypromellose) in fasted state (treatment C), 2.4 mg of GSK2798745 (micronized API with SLS and hypromellose) in fasted state (treatment B), 2.4 mg single oral doses of GSK2798745 (micronized API without SLS and hypromellose) in fasted state (treatment A), and GSK2798745 tablet in fed state (treatment D) in either treatment periods 1, 2, or 3; the three treatment periods will each be separated by a minimum washout period of 7 days

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Between 18 and 75 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, 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 in consultation with the Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
Body weight >=50 kg and body mass index within the range 18 - 32 kilogram (kg)/meter (m)^2 (inclusive)
Male or female of non-child bearing potential:
A male subject with a female partner of child bearing potential is eligible to participate if he agrees to use contraception as mentioned in the protocol during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period A female subject is eligible to participate if she is not a woman of childbearing potential (WOCBP) as defined in the protocol.

Key exclusion criteria (18 listed)

History of acute coronary syndromes including unstable angina or myocardial infarction within 6 months of screening
History of stroke or seizure disorder within 5 years of Screening
Active ulcer disease or gastrointestinal bleeding at the time of screening
Alanine transaminase (ALT) and bilirubin >1.5x Upper limit of normal (ULN) 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)

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
GSK2798745 Micronized API without SLS and hypermellose (Tablet A)This is an immediate release tablet containing 2.4 mg of micronized GSK2798745 API; to be administered orally with 240 mL of water under fasted/fed conditions	Drug	GSK2798745 ABCD treatment sequence, GSK2798745 ACBD treatment sequence, GSK2798745 BACD treatment sequence, GSK2798745 BCAD treatment sequence, GSK2798745 CABD treatment sequence, GSK2798745 CBAD treatment sequence
GSK2798745 Micronized API with SLS and hypermellose (Tablet B)This is an immediate release tablet containing 2.4 mg of micronized GSK2798745 API with SLS and hypermellose; to be administered orally in fasted/fed conditions with 240 mL of water	Drug	GSK2798745 ABCD treatment sequence, GSK2798745 ACBD treatment sequence, GSK2798745 BACD treatment sequence, GSK2798745 BCAD treatment sequence, GSK2798745 CABD treatment sequence, GSK2798745 CBAD treatment sequence
GSK2798745 milled API without SLS and hypermellose (Tablet C)This is an immediate release tablet containing 2.4 mg of milled GSK2798745 API with SLS and hypermellose; to be administered orally in fasted/fed conditions, with 240 mL of water	Drug	GSK2798745 ABCD treatment sequence, GSK2798745 ACBD treatment sequence, GSK2798745 BACD treatment sequence, GSK2798745 BCAD treatment sequence, GSK2798745 CABD treatment sequence, GSK2798745 CBAD treatment sequence

Primary outcome

Area under the curve (AUC) of GSK2798745
Time frame: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in each of the treatment periods
AUC will be determined following a single oral dose of GSK2798745 under fasted conditions (Treatment periods 1-3) and fed conditions (Treatment period 4)
Maximum plasma concentration (Cmax) of GSK2798745
Time frame: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in each of the treatment periods
Cmax will be determined following a single oral dose of GSK2798745 under fasted conditions (Treatment periods 1-3) and fed conditions (Treatment period 4)

16 secondary outcomes

Time to maximum observed concentration (Tmax) of GSK2798745
Time frame: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in each of the treatment periods
Elimination half-life (T1/2) of GSK2798745
Time frame: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in each of the treatment periods
AUC of GSK2798745 following a standard Food Drug Administration (FDA) high fat, high calorie meal
Time frame: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in treatment period 4
Cmax of GSK2798745 following a standard FDA high fat, high calorie meal
Time frame: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in treatment period 4
Systolic and diastolic blood pressure as a measure of safety and tolerability of GSK2798745
Time frame: Up to 11 weeks
Pulse rate as a measure of safety and tolerability of GSK2798745
Time frame: Up to 11 weeks
Respiratory rate as a measure of safety and tolerability of GSK2798745
Time frame: Up to 11 weeks
Safety and tolerability of single dose of GSK2798745 as assessed by electorcardiograms (ECGs)
Time frame: Up to 11 weeks
Safety and tolerability of single dose of GSK2798745 as assessed by hematology
Time frame: At Baseline (Day -1)
Safety and tolerability of single dose of GSK2798745 as assessed by clinical chemistry
Time frame: At Baseline (Day -1)
Safety and tolerability of single dose of GSK2798745 as assessed by urinalysis
Time frame: At Baseline (Day -1)
Safety and tolerability of single dose of GSK2798745 as assessed by liver function tests (LFTs)
Time frame: At Baseline (Day -1)
Safety and tolerability of single dose of GSK2798745 as assessed by weight assessments
Time frame: Up to 11 weeks
Safety and tolerability of single dose of GSK2798745 as assessed by appetite assessments
Time frame: Up to 11 weeks
Safety and tolerability of single dose of GSK2798745 as assessed by troponin measurement
Time frame: At Baseline (Day -1) and 24 hours post dose on Day 2
Number of subjects with any adverse events (AEs) as a measure of safety and tolerability of GSK2798745
Time frame: Up to 11 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 25 Jan 2017.

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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?

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 6 inclusion and 18 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 25 Jan 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 States. 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 curve (AUC) of GSK2798745 (time frame: Blood samples will be collected at the following time points: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 15 (Day 1), 24 and 36 (Day 2), 48 (Day 3) and 72 hours (Day 4) post dose in each of the treatment periods). 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 NCT02925546.

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 25 Jan 2017.