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NCT02345707 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability Study of Phase III Tablet Formulation of Cabotegravir
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT02345707 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 37 participants.
The verdict
NCT02345707, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt tablet formulations relative to the current CAB sodium salt formulation being used in the phase IIb studies under fasting conditions. All treatments will be administered as single 30 mg doses of CAB. 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. Treatment period doses will be separated by a 14 day washout. Participation in this study will be approximately 12 weeks.
Interventions
- DRUG Cabotegravir 30 mg current formulation
- DRUG Cabotegravir 30 mg micronized new formulation 500 M
- DRUG Cabotegravir 30 mg unmicronized new formulation 500 U
- DRUG Cabotegravir 30 mg micronized new formulation 650 M
- DRUG Cabotegravir 30 mg unmicronized new formulation 650 U
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2015-03 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02345707
The ClinicalTrials.gov registry entry for NCT02345707 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 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 0 conditions, and to 5 interventions - of which Cabotegravir 30 mg current formulation is the first listed.
NCT02345707 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02345707 about?
NCT02345707 is a clinical study titled "Relative Bioavailability Study of Phase III Tablet Formulation of Cabotegravir". This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt tablet formulations relative to the current CAB sodium salt formulation being used in the phase IIb studies under f...
What is the current status of trial NCT02345707?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2015-03. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02345707?
The interventions under investigation include: Cabotegravir 30 mg current formulation (DRUG), Cabotegravir 30 mg micronized new formulation 500 M (DRUG), Cabotegravir 30 mg unmicronized new formulation 500 U (DRUG), Cabotegravir 30 mg micronized new formulation 650 M (DRUG), Cabotegravir 30 mg unmicronized new formulation 650 U (DRUG).
Who is sponsoring clinical trial NCT02345707?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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