Healthy Volunteer Clinical Trial
Official title:
A Phase I, Open Label, Randomized, Three Period, One-way, Two Cohort, Adaptive Crossover Study to Evaluate the Effect of Darunavir/Ritonavir Plus Etravirine and Lopinavir/Ritonavir Plus Etravirine on GSK1349572 Pharmacokinetics in Healthy Adult Subjects (ING112934)
A Phase I, open label, randomized, three period, one-way, two cohort, adaptive crossover study to evaluate the effect of darunavir/ritonavir plus etravirine and lopinavir/ritonavir plus etravirine on GSK1349572 pharmacokinetics in healthy adult subjects
The study is a three period, randomized, open label study. Approximately 18 healthy subjects will receive GSK1349572 50mg q24h for 5 days (Treatment A) in Period 1. Subjects will then be administered GSK1349572 50mg q24h in combination with either LPV/RTV 400/100 mg q12h and etravirine 200mg q12h (Treatment B, n=9) or DRV/RTV 600/100 mg q12h and etravirine 200mg q12h (Treatment C, n=9) for 14 days in Period 2 followed by a washout period. GSK1349572 PK data will be obtained from Periods 1 and 2 and used to inform decision making on Period 3. If GSK1349572 Cτ is reduced by more than 50% in Period 2 compared to Period 1, subjects will return to the clinic and receive GSK1349572 50mg q12h in combination with ETV and either DRV/RTV or LPV/RTV in Period 3. 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. All doses of study drugs will be taken following a moderate fat meal. ;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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