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NCT02059031 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess The Relative Bioavailability of New Tablet Formulations of GSK1265744 in Healthy Adult Subjects
A Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT02059031: Completed Phase 1 study of Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare.
NCT02059031 is a Phase 1 study of Infection, Human Immunodeficiency Virus that has completed, run by ViiV Healthcare. The registered enrollment target is 24 participants, below the 146-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02059031, a Phase 1 study of Infection, Human Immunodeficiency Virus, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate two new GSK1265744 sodium salt tablet formulations and provide data for selection of one of these tablet formulations for use in Phase 3. This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects. Part A is a randomized, open-label, 3-way balanced cross-over design in 24 subjects to assess the oral bioavailability of two GSK1265744 sodium salt tablet formulations relative to the current GSK1265744 sodium salt formulation being used in the phase IIb studies under fasting conditions. Part A treatment periods will be separated by a 14 day washout. After completion of Part A, preliminary PK data will be analyzed and a decision will be made based on pre-specified criteria, as to which formulation will be used to conduct Part B. Fifteen subjects who will have participated in Part A will participate in Part B and receive the selected formulation with a moderate fat meal. All treatments will be administered as single 30 mg doses of GSK1265744. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study drug.
Primary Outcome
PK parameters will include area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC\[0-infinity\]), AUC from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC\[0-t\]), maximum observed concentration (Cmax) and concentration at 24h post-dose (C24)
Conditions Studied
Interventions
- DRUG GSK1265744 Reference formulation
- DRUG GSK1265744 New formulation 1
- DRUG GSK1265744 New formulation 2
Study Locations (1)
Kansas
- GSK Investigational Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-02 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT02059031 record still lists
NCT02059031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 146-participant average among 19 other Infection, Human Immunodeficiency Virus trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Infection, Human Immunodeficiency Virus appearing as the primary indexed condition, and to 3 interventions - of which GSK1265744 Reference formulation is the first listed.
NCT02059031 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT02059031 about?
NCT02059031 is a clinical study titled "A Study to Assess The Relative Bioavailability of New Tablet Formulations of GSK1265744 in Healthy Adult Subjects". This study will evaluate two new GSK1265744 sodium salt tablet formulations and provide data for selection of one of these tablet formulations for use in Phase 3. This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects. Part A is a randomized, open-label,...
What is the current status of trial NCT02059031?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2014-02. Estimated completion is 2014-06.
What conditions does trial NCT02059031 study?
This clinical trial studies the following conditions: Infection, Human Immunodeficiency Virus.
What interventions are being tested in trial NCT02059031?
The interventions under investigation include: GSK1265744 Reference formulation (DRUG), GSK1265744 New formulation 1 (DRUG), GSK1265744 New formulation 2 (DRUG).
Who is sponsoring clinical trial NCT02059031?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02059031 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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Where NCT02059031's enrollment target sits among peer trials
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