Phase I Study of GSK2982772 in Japanese Healthy Male Participants
Status:
Completed
Trial end date:
2018-09-26
Target enrollment:
Participant gender:
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.