A Drug Interaction Study Evaluating GSK2248761 and Raltegravir Pharmacokinetics in Healthy Adult Subjects

Summary

In this study, approximately 16 subjects will receive raltegravir 400mg twice daily for 5 days (Treatment A) followed by a washout period. In Period 2, subjects will receive GSK2248761 200mg once daily for 5 days (Treatment B). There will be no wash out between Period 2 and 3. Subjects will then be administered raltegravir 400mg twice daily in combination with GSK2248761 200mg once daily (Treatment C) for 5 days. Subjects will be housed in the unit for the duration of the study. 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

2010-04

Primary completion

2010-06

Completion

2010-06

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