Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of GSK2881078 in Single and Repeat Doses
Status:
Completed
Trial end date:
2015-03-26
Target enrollment:
Participant gender:
Summary
This study is the first administration of GSK2881078 to humans. The intention of this study
is to provide sufficient confidence in the safety of the molecule to inform progression to
further repeat dose and proof of concept studies. This study will include approximately 52
subjects and consist of 2 parts. Part A will consist of two cohorts of 8 subjects to assess
the safety, tolerability, and pharmacokinetic (PK) of ascending single oral doses of
GSK2881078. Cohorts 1 and 2 will include healthy male subjects. Part B (Cohorts 3, 4 and 5)
will include three cohorts of 12 healthy male subjects to examine the safety, tolerability,
PK, and pharmacodynamic (PD) of repeated doses of GSK2881078 over 14 days. The total duration
of the study including screening and follow-up, is not expected to exceed 70 days.