Healthy Subjects Clinical Trial
Official title:
A Randomized, Open-Label, Single‑Dose, 3‑Period, Crossover Evaluation of the Relative Bioavailability of Two Experimental Fixed-Dose Combination Tablet Formulations of Dolutegravir 50 mg/Abacavir 600 mg/Lamivudine 300 mg Compared to Co‑Administered Dolutegravir 50 mg and EPZICOM™ (Abacavir 600 mg/Lamivudine 300 mg) Tablets in Healthy Adult Subjects
Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in
phase 3 clinical trials for human immunodeficiency virus (HIV). Fixed-dose combinations
(FDCs) have greatly simplified the treatment of patients with HIV. While Atripla (an FDC of
tenofovir (TDF), emtricitabine (FTC) and efavirenz (EFV)) has become the preferred first
line regimen due in large part to its convenient presentation as a full treatment regimen in
a single product, other options are needed. A fixed-dose combination of DTG/abacavir
(ABC)/lamivudine (3TC) is one such opportunity.
This is a single-center, randomized, open-label, 3-period crossover study in healthy adult
subjects to evaluate the single-dose relative bioavailability of two experimental oral DTG
50 mg/ABC 600 mg/3TC 300 mg FDC tablet formulations compared to co-administration of the
separate tablet formulations (DTG 50 mg tablet and EPZICOM), with each dose administered in
the fasted state. Approximately 18 subjects will be enrolled and randomized to one of 6
different treatment sequences. There will be a screening visit within 30 days prior to the
first dose of study drug and a follow up visit within 7-14 days after the last dose. There
will be a 7 day washout between doses in each treatment period.
The following PK parameters for DTG, ABC and 3TC will be measured: area under the
concentration curve from time zero (pre-dose) extrapolated to infinite time
(AUC(0-infinity)), Area under the concentration-time curve from time zero (pre-dose) to the
time of the last quantifiable concentration (AUC (0-t)), maximum observed concentration
(Cmax), lag time before observation of drug concentrations (tlag), time of occurrence of
Cmax (tmax), terminal phase half-life (t½), apparent clearance following oral dosing (CL/F)
and apparent terminal phase volume of distribution (Vz/F).
Official Title - Randomized, Open-Label, Single Dose, 3 Period, Crossover Evaluation of the
Relative Bioavailability of Two Experimental Fixed-Dose Combination Tablet Formulations of
Dolutegravir 50 mg/Abacavir 600 mg/Lamivudine 300 mg Compared to Co administered
Dolutegravir 50 mg and EPZICOM™ (Abacavir 600 mg/Lamivudine 300 mg) Tablets in Healthy Adult
Subjects.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
updating systems to reflect the change in sponsorship
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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