GSK1349572 Drug Interaction With Tenofovir
This study has been completed.
Information provided by:
First received: July 29, 2008
Last updated: October 14, 2010
Last verified: October 2010
A study in healthy volunteers to determine whether there is a drug interaction between GSK1349572 and tenofovir
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
|Official Title:||A Phase I, Open Label, Single Sequence,Drug Interaction Study Evaluating Plasma GSK1349572 and Tenofovir Pharmacokinetics in Healthy Adult Subjects (ING111604)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Plasma GSK1349572 steady-state AUC(0-tau), Cmax and Ctau following administration of GSK1349572 50 mg q24h for 5 days and following co-administration with TDF 300 mg q24h for 5 days
Secondary Outcome Measures:
- Plasma tenofovir steady-state AUC(0-24), Cmax and Ct following administration of TDF 300 mg q24h for 7 days alone and following co-administration with GSK1349572 50 mg q24h for 5 days.
- Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, ECG, and vital signs assessments.
|Study Start Date:||August 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Drug: GSK1349572 and tenofovir
Other Name: GSK1349572 and tenofovir
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