NCT01209065

GSK1349572 Drug Interaction Study With Fosamprenavir/Ritonavir

Phase I, Open Label, Two Period Study to Evaluate the Effects of Fosamprenavir/Ritonavir on GSK1349572 Pharmacokinetics and a Phase I, Randomized, Three-Way Crossover Study to Evaluate the Relative Bioavailability of Three Tablet Variants Made Using Micronized, Unmicronized and Intermediate Particle Sizes of GSK1349572 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

GSK1349572 is an integrase inhibitor being developed for the treatment of human immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of Shionogi-ViiV HealthcareLLC. In HIV-infected patients where combination antiretroviral therapy is the standard of care, it is likely that it will be dosed with boosted protease inhibitors (PIs) including fosamprenavir/ritonavir (FPV/RTV or FPV/r). As FPV and RTV are modulators (induction as well as inhibition) of Uridine diphosphate glucuronosyltransferase (UGT) and Cytochrome P450 (CYP)3A which are the primary and secondary metabolic pathways of GKS1349572, it is likely that FPV/RTV will affect the pharmacokinetics (PK) of GSK1349572, therefore a drug interaction study is warranted and will be evaluated in Part A of this study. Part B will evaluate the effect of particle size of tablet variants on the PK of GSK1349572. In Part A, approximately 12 subjects will receive GSK1349572 50mg every 24 hours (q24h) for 5 days (Treatment A). Subjects will then be administered GSK1349572 50mg q24h in combination with FPV/RTV 700/100 mg every 12 hours (q12h) (Treatment B) for 10 days. There will be no washout between treatments. In Part B 15 subjects will receive a single 50 mg dose (2 x 25mg tablet) in 3 different tablet variants of the same formulation, differing only in particle sizes of GSK1349572, under fasted conditions in a three-way crossover design. 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.

Detailed description

Official Study Title: Phase I, open label, two period, study to evaluate the effects of fosamprenavir/ritonavir on GSK1349572 pharmacokinetics and a phase I, randomized, three-way crossover study to evaluate the relative bioavailability of three tablet variants made using micronized, unmicronized and intermediate particle sizes of GSK1349572 in healthy adult subjects (ING113068). ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Conditions

• Infections, Human Immunodeficiency Virus and Herpesviridae

Interventions

Type	Name	Description
DRUG	GSK1349572	GSK1349572 is an integrase inhibitor being developed for the treatment of human immunodeficiency virus -1 infection by ViiV Healthcare. This drug is experimental and has not been approved by the Food and Drug Administration (FDA).
DRUG	Fosamprenavir	Fosamprenavir is a drug in the protease inhibitor class that is approved by the FDA for the treatment of HIV infection.
DRUG	Ritonavir	Ritonavir is a drug in the protease inhibitor class that is approved by the FDA for the treatment of HIV infection.

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-09-24
• Last updated: 2017-01-19

Locations

1 site across 1 country: United States