drugset / Trial / NCT01978327
GSK2647544 RD, DDI in Healthy Young and Elderly Volunteers
RandomizedCrossoverSingle-blindTreatment
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK2647544 | Small molecule | 80 mg | Oral |
| Subject | GSK2647544 | Small molecule | 200 mg | Oral |
| Subject | GSK2647544 | Small molecule | 350 mg | Oral |
| Subject | Simvastatin | Small molecule | — | — |