drugset / Trial / NCT01299597

A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers.

NCT01299597

Phase 1 Completed 30 enrolled GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The present study will investigate in humans the enzyme inhibition effects of SB-649868 on CYP3A4, using Simvastatin and Atorvastatin as CYP3A4 probe substrates, administered as single doses: alone, and on two different occasions after repeat doses of SB-649868, at the same time as SB-649868 and 2h before SB-649868.

Timeline

Start
2010-01-18
Primary completion
2010-02-26
Completion
2010-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Atorvastatin Small molecule 20 mg
Subject SB-649868 Small molecule 20 mg
Subject Simvastatin Small molecule 10 mg

Indications