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NCT01366547 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability Study of Two New Dolutegravir/Abacavir/Lamivudine Fixed Dose Combination Tablets
A Phase 1 study of Healthy Subjects and Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01366547 is a Phase 1 study of Healthy Subjects and Infection, Human Immunodeficiency Virus that has completed, run by ViiV Healthcare. The registered enrollment target is 18 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01366547, a Phase 1 study of Healthy Subjects and Infection, Human Immunodeficiency Virus, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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. 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).
Conditions Studied
Interventions
- DRUG Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg
- DRUG Dolutegravir 50 mg
- DRUG abacavir 600 mg/lamivudine 300 mg
Study Locations (1)
New York
- GSK Investigational Site - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-06 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01366547
The ClinicalTrials.gov registry entry for NCT01366547 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (86% lower). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy Subjects appearing as the primary indexed condition, and to 3 interventions - of which Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg is the first listed.
NCT01366547 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01366547 about?
NCT01366547 is a clinical study titled "Relative Bioavailability Study of Two New Dolutegravir/Abacavir/Lamivudine Fixed Dose Combination Tablets". 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), emtricitabin...
What is the current status of trial NCT01366547?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-06. Estimated completion is 2011-07.
What conditions does trial NCT01366547 study?
This clinical trial studies the following conditions: Healthy Subjects, Infection, Human Immunodeficiency Virus.
What interventions are being tested in trial NCT01366547?
The interventions under investigation include: Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg (DRUG), Dolutegravir 50 mg (DRUG), abacavir 600 mg/lamivudine 300 mg (DRUG).
Who is sponsoring clinical trial NCT01366547?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01366547 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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