A Phase I, Randomized, Placebo-controlled, Double Blind, Repeat Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Gastrointestinal Transit Time and Pharmacodynamic Biomarkers of GSK3179106 in Normal Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-11-30

Brief Summary

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The current study is designed to assess the safety, tolerability, pharmacokinetics (PK), gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses of GSK3179106 administered for 14 days in normal healthy subjects. It is a randomized, double-blind, placebo-controlled, ascending cohort study. A total of 48 subjects will be randomized (8 subjects/cohort) with 3:1 allocation to GSK3179106 or matching placebo.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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10 mg of GSK3179106 QD-Cohort 1

Eligible six subjects will receive 10 mg oral dose once daily for 14 days

Group Type EXPERIMENTAL

GSK3179106

Intervention Type DRUG

It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

50 mg of GSK3179106 QD-Cohort 2

Eligible six subjects will receive 50 mg oral dose once daily for 14 days

Group Type EXPERIMENTAL

GSK3179106

Intervention Type DRUG

It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

200 mg of GSK3179106 QD-Cohort 3

Eligible six subjects will receive 200 mg oral dose once daily for 14 days

Group Type EXPERIMENTAL

GSK3179106

Intervention Type DRUG

It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

400 mg of GSK3179106 QD-Cohort 4

Eligible six subjects will receive 400 mg oral dose once daily for 14 days

Group Type EXPERIMENTAL

GSK3179106

Intervention Type DRUG

It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

25 mg of GSK3179106 BID-Cohort 5

Eligible six subjects will receive 25 mg oral dose twice daily for 14 days

Group Type EXPERIMENTAL

GSK3179106

Intervention Type DRUG

It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

200 mg of GSK3179106 BID-Cohort 6

Eligible six subjects will receive 200 mg oral dose twice daily for 14 days

Group Type EXPERIMENTAL

GSK3179106

Intervention Type DRUG

It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

Matching placebo QD-Cohort 1, 2, 3, 4

Eligible two subjects, per cohort, will receive oral dose of matched placebo once daily for 14 days

Group Type PLACEBO_COMPARATOR

Matched Placebo

Intervention Type DRUG

It is uncoated round or oblong placebo tablet prepared to match actives across all strengths. It is White to slightly colored tablet and will be administered orally

Matching placebo BID-Cohort 5, 6

Eligible two subjects, per cohort, will receive oral dose of matched placebo twice daily for 14 days

Group Type PLACEBO_COMPARATOR

Matched Placebo

Intervention Type DRUG

It is uncoated round or oblong placebo tablet prepared to match actives across all strengths. It is White to slightly colored tablet and will be administered orally

Interventions

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GSK3179106

It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally

Intervention Type DRUG

Matched Placebo

It is uncoated round or oblong placebo tablet prepared to match actives across all strengths. It is White to slightly colored tablet and will be administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
* Healthy as determined by the investigator based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. History of regular bowel habits
* Male or Female of non-childbearing potential.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions

Exclusion Criteria

* ALT and bilirubin \>1.5xupper limit of normal (ULN) (isolated bilirubin \>1. ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
* Estimated Glomerular Filtration Rate \<60 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2)
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* History of Gastroesophageal reflux disease (GERD), dyspepsia, GI bleeding, GI surgery that could affect motility

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes