Infections, Human Immunodeficiency Virus and Herpesviridae Clinical Trial
Official 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
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.
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
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