NCT02801981

Dose-escalation Study of GSK2330672 in Japanese Healthy Male Volunteers

A Double-blind, Randomized, Placebo Controlled, Dose Escalating Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Parameters of Single Doses of GSK2330672 in Japanese Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 20 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study will be the first to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics following single dose of 10 milligrams (mg) to 180 mg of GSK2330672 in Japanese healthy subjects. This is a double-blind, randomized, placebo-controlled, dose-escalating and incomplete block crossover study to be conducted in 16 Japanese healthy subjects. Study will be conducted in four periods; subjects will receive either placebo or GSK2330672 (10 mg, 30 mg, 90 mg or 180 mg based on randomization) in each treatment period. Each period will be separated by washout period (at least 6 days from dosing). Total duration of study for each subject will be approximately 5 weeks from the first dosing to follow up visit.

Conditions

• Cholestasis

Interventions

Type	Name	Description
DRUG	GSK2230672	It will be supplied as white to slightly colored, round, film coated tablet for oral administration containing 10 mg or 45 mg of GSK2330672.
DRUG	Placebo	It will be supplied as placebo tablets (with no GSK2230672) visually matching to GSK2230672

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-06-16
• Last updated: 2016-11-09

Locations

1 site across 1 country: Japan