Phase 1 Study of GSK2315698 in Healthy Japanese Subjects
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
This is the first study in which GSK2315698 will be administered in Japanese population. The
primary objective of the study is to investigate safety and tolerability, pharmacokinetics,
and pharmacodynamics after single intravenous infusion in healthy subjects. This will be a
single center, double-blind, randomized, placebo-controlled, dose-ascending study.
Subjects in Cohort 1 will attend 3 dosing sessions, and will be randomized to one of the 3
groups. Each group will receive GSK2315698 and Placebo in a defined sequence. The dose levels
of GSK2315698 are set to 10 milligrams (mg) per hour (hr), 20 mg/hr, and 40 mg/hr, to be
administered over 1 hour. Dosing sessions 1 and 2, and dosing sessions 2 and 3, will be
separated by a washout period of at least 8 and 10 days, respectively.
Subjects in Cohort 2 will attend a single dosing session, and will be randomized to receive
either GSK2315698 20 mg/hr or Placebo, over a period of 15 hours.
A sufficient number of subjects will be randomized such that 18 subjects (9 in each cohort)
complete the study. The duration of participation for any subject in this study will be
approximately 59 days.