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

Phase 1

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: GSK3179106; Drug: Matched Placebo

• Registration Number: NCT02798991
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-09
• Study First Posted: 2016-06-14
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 mg of GSK3179106 QD-Cohort 2	GSK3179106	Eligible six subjects will receive 50 mg oral dose once daily for 14 days
10 mg of GSK3179106 QD-Cohort 1	GSK3179106	Eligible six subjects will receive 10 mg oral dose once daily for 14 days
200 mg of GSK3179106 QD-Cohort 3	GSK3179106	Eligible six subjects will receive 200 mg oral dose once daily for 14 days
200 mg of GSK3179106 BID-Cohort 6	GSK3179106	Eligible six subjects will receive 200 mg oral dose twice daily for 14 days
Matching placebo BID-Cohort 5, 6	Matched Placebo	Eligible two subjects, per cohort, will receive oral dose of matched placebo twice daily for 14 days
Matching placebo QD-Cohort 1, 2, 3, 4	Matched Placebo	Eligible two subjects, per cohort, will receive oral dose of matched placebo once daily for 14 days
400 mg of GSK3179106 QD-Cohort 4	GSK3179106	Eligible six subjects will receive 400 mg oral dose once daily for 14 days
25 mg of GSK3179106 BID-Cohort 5	GSK3179106	Eligible six subjects will receive 25 mg oral dose twice daily for 14 days

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse event (AE)	Up to Day 25	An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

Trial Locations

Locations (1)

GSK Investigational Site; 🇦🇺 Adelaide, South Australia, Australia