A Drug Interaction Study Between Simvastatin, Atorvastatin, Rosuvastatin, and GSK2248761 in Healthy Subjects.

Summary

This study is a Phase I, open-label, single-sequence drug interaction study to evaluate the effect of repeated doses of GSK2248761 on the pharmacokinetics of simvastatin, atorvastatin, and rosuvastatin in healthy adult subjects. In this study, approximately 14 subjects will receive single doses of simvastatin, atorvastatin, and rosuvastatin on two occasions, once alone and once following administration of repeated doses of GSK2248761. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-14 days after the last dose of study drug.

Timeline

Start

2010-06

Primary completion

2010-08

Completion

2010-08

Publications

• Piscitelli S, Kim J, Gould E, Lou Y, White S, de Serres M, Johnson M, Zhou XJ, Pietropaolo K, Mayers D. Drug interaction profile for GSK2248761, a next generation non-nucleoside reverse transcriptase inhibitor. Br J Clin Pharmacol. 2012 Aug;74(2):336-45. doi: 10.1111/j.1365-2125.2012.04194.x.

Drugs

Indications