NCT01622790

Evaluation of the Bioequivalence of a Combined Formulated Tablet

An Evaluation of the Bioequivalence of a Combined Formulated Tablet (50mg/600mg/300mg Dolutegravir/Abacavir/Lamivudine) Compared to One Dolutegravir 50mg Tablet and One EPZICOM† (600mg/300mg Abacavir/Lamivudine) Tablet Administered Concurrently and the Effect of Food on Bioavailability of the Combined Formulation in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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. Part A of this study will be a single-dose, two-treatment crossover pivotal bioequivalence (BE) evaluation of the DTG/ABC/3TC FDC tablet in 66 healthy subjects. The reference formulations in this trial will be the 50 mg DTG tablet that is currently being used in the Phase 3 clinical trials and the already marketed FDC tablet product EPZICOM™ (ABC 600 mg/3TC 300 mg).It is intended that the results of this pivotal bioequivalence study will show that the proposed commercial DTG/ABC/3TC FDC tablet formulation is bioequivalent to DTG plus EPZICOM administered as separate tablets. Part B of this study will evaluate the effect of a high fat meal on the FDC tablet in 12 healthy subjects that have already participated in Part A of the study. 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), terminal elimination phase rate constant (λz), percentage of AUC obtained by extrapolation (%AUCex),apparent clearance following oral dosing (CL/F) and apparent terminal phase volume

Conditions

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg	Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg is an experimental fixed dose combination tablet of an experimental integrase inhibitor (dolutegravir) and two FDA approved nucleoside reverse transcriptase inhibitors (abacavir and lamivudine)
DRUG	Dolutegravir 50 mg	Dolutegravir is an experimental drug in the integrase inhibitor class that is being studied for the treatment of HIV infection.
DRUG	abacavir 600 mg/lamivudine 300 mg	This is an FDA approved fixed dose combination tablet of two nucleoside reverse transcriptase inhibitors

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-06-19
• Last updated: 2012-10-15

Locations

1 site across 1 country: United States