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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: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT02345707 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the relative bioavailability of cabotegravir after single 30 mg dose in the fasted state, the following PK parameters will be assessed: 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) and concentration at 24 hours post-dos
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 |
What the finished NCT02345707 record still lists
NCT02345707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 5 interventions - of which Cabotegravir 30 mg current formulation is the first listed.
NCT02345707 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02345707's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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