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NCT01622790 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Bioequivalence of a Combined Formulated Tablet
A Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT01622790 is a Phase 1 study of Infection, Human Immunodeficiency Virus that has completed, run by ViiV Healthcare. The registered enrollment target is 66 participants, below the 144-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01622790, a Phase 1 study of Infection, Human Immunodeficiency Virus, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 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. 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 h
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)
Kansas
- GSK Investigational Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2012-06 |
| Est. Completion | 2012-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01622790
The ClinicalTrials.gov registry entry for NCT01622790 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 144-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (54% lower). The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Infection, Human Immunodeficiency Virus 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.
NCT01622790 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.
Frequently Asked Questions
What is clinical trial NCT01622790 about?
NCT01622790 is a clinical study titled "Evaluation of the Bioequivalence of a Combined Formulated Tablet". 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 NCT01622790?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2012-06. Estimated completion is 2012-08.
What conditions does trial NCT01622790 study?
This clinical trial studies the following conditions: Infection, Human Immunodeficiency Virus.
What interventions are being tested in trial NCT01622790?
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 NCT01622790?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01622790 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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