GSK2647544 RD, DDI in Healthy Young and Elderly Volunteers

Summary

GSK2647544 is an orally available, selective inhibitor of Lp PLA2 that is being developed for the treatment of Alzheimer's disease. The current study is a single-blind, randomised, placebo-controlled, 4-cohort study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of repeat doses of GSK2647544. Cohorts 1, 2 and 3 will evaluate escalating doses of GSK2647544 in young healthy volunteers for 7 days, 7 days, and 14 days, respectively. Cohort 4 will evaluate repeat doses of GSK2647544 in healthy elderly volunteers for 14 days. Additionally, Cohorts 1 and 3 will include an assessment of potential drug-drug interaction with simvastatin to examine CYP3A4 inhibition by GSK2647544.

Timeline

Start

2013-11-22

Primary completion

2014-03-03

Completion

2014-03-03

Outcome

Outcome not reported

Stopped: “Given the strength of CYP3A4 inhibition observed in Cohort 1, there is no rationale to investigate higher doses of GSK2647544 in the following two cohorts”

Drugs

Indications