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NCT01382238 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability Study of a Pediatric Granule Formulation of Dolutegravir
A Phase 1 study of Infections, Human Immunodeficiency Virus and Herpesviridae, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01382238 is a Phase 1 study of Infections, Human Immunodeficiency Virus and Herpesviridae that has completed, run by ViiV Healthcare. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01382238, a Phase 1 study of Infections, Human Immunodeficiency Virus and Herpesviridae, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor currently in Phase 3 clinical trials for the treatment of human immunodeficiency virus (HIV) infection. A granule formulation has been developed as an alternative to the current tablet formulation for administration in pediatric populations. This is a single-center, randomized, open-label, 5-way crossover study in healthy adult subjects. The study will evaluate the relative bioavailability of a 50 mg granule formulation of dolutegravir when administered 1) directly to mouth; 2) with purified water; 3) with Contrex brand water; and 4) with milk-based infant formula compared to the current 50 mg tablet formulation administered with tap water. Safety evaluations and serial PK samples will be collected during each treatment period. A taste assessment of the granule will also be performed. A follow-up visit will occur 5-7 days after the last dose of study drug. Pharmacokinetic assessments during the study will include area under the concentration-time 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 last time of quantifiable concentration within a subject across all treatments (AUC(0-t)), maximum observed concentration (Cmax), terminal phase half-life (t½), lag time before observation of drug concentrations in sampled matrix (tlag), time of occurrence of Cmax (tmax), concentration at 24 hours post-dose (C24), and apparent clearance following oral dosing (CL/F).
Conditions Studied
Interventions
- DRUG Dolutegravir 50 mg tablet
- DRUG Dolutegravir 50 mg oral granules
Study Locations (1)
Texas
- GSK Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-06 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01382238
The ClinicalTrials.gov registry entry for NCT01382238 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Infections, Human Immunodeficiency Virus and Herpesviridae appearing as the primary indexed condition, and to 2 interventions - of which Dolutegravir 50 mg tablet is the first listed.
NCT01382238 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01382238 about?
NCT01382238 is a clinical study titled "Relative Bioavailability Study of a Pediatric Granule Formulation of Dolutegravir". Dolutegravir (DTG, GSK1349572) is an integrase inhibitor currently in Phase 3 clinical trials for the treatment of human immunodeficiency virus (HIV) infection. A granule formulation has been developed as an alternative to the current tablet formulation for administration in pediatric populations. ...
What is the current status of trial NCT01382238?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-06. Estimated completion is 2011-08.
What conditions does trial NCT01382238 study?
This clinical trial studies the following conditions: Infections, Human Immunodeficiency Virus and Herpesviridae.
What interventions are being tested in trial NCT01382238?
The interventions under investigation include: Dolutegravir 50 mg tablet (DRUG), Dolutegravir 50 mg oral granules (DRUG).
Who is sponsoring clinical trial NCT01382238?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01382238 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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