NCT03590613

Phase I Study of GSK2982772 in Japanese Healthy Male Participants

A Single-centre, Randomized, Double-blind, Dose-ascending, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral TID Doses (One Day) of GSK2982772 in Japanese Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 20 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The study plans to enroll approximately 12 subjects. The main objective of the study is to assess the safety, tolerability and pharmacokinetics (PK) of the three times a day (TID), dosing of GSK2982772, in Japanese healthy male subjects. The study will comprise of four study periods each at least 7 days in duration with subjects in-house for 4 nights (through 72 hrs after the first dose). During each treatment period (TP), subjects will be admitted to the unit the day before dosing and will be discharged after completion of the 72 hours post-dose assessments. There will be a washout of atleast 7-days between the TP doses for each individual, post which there will be 7-days follow-up. The dose range proposed in this study is based on a low starting dose, which will be escalated to the highest dose that is intended for the Phase 2b dose range study. The decision to proceed to the next dose-level, of GSK2982772 within the study will be made by principal investigator and GSK Medical Monitor per each dosing periods. The study duration is approximately 22 weeks.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	GSK2982772	GSK2982772 will be available as white to almost white, round, film coated tablets to be administered via oral route
DRUG	Placebo	Placebo matching GSK2982772 will be available as white to almost white, round, film coated tablets to be administered via oral route.

Timeline

• Start date: 2018-07-19
• Primary completion: 2018-09-21
• Completion: 2018-09-26
• First posted: 2018-07-18
• Last updated: 2023-10-04
• Results posted: 2019-09-17

Locations

1 site across 1 country: Japan