drugset / Trial / NCT00942136

GSK1349572 Proton Pump Inhibitor Drug Interaction and Supratherapeutic Dose Study

NCT00942136

Phase 1 Completed 24 enrolled GlaxoSmithKline Shionogi · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

GSK1349572 is an integrase inhibitor that is currently being evaluated for the treatment of HIV infection. The primary objective of this study is to determine whether the addition of a proton pump inhibitor, omeprazole, to GSK1349572 impacts the blood levels of GSK1349572. It will also evaluate if a high fat meal impacts the blood levels of GSK1349572. In addition, the safety, tolerability, and pharmacokinetics of single supratherapeutic (high) dose of GSK1349572 will be evaluated.

Timeline

Start
2009-07
Primary completion
2009-09
Completion
2009-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Dolutegravir Other / unclassified 50 mg
Subject Dolutegravir Other / unclassified 250 mg
Subject Omeprazole Other / unclassified 40 mg

Indications

No indication recorded.