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NCT01837719 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT01837719: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT01837719 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01837719, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.
Primary Outcome
Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data.
Interventions
- DRUG Cobicistat
- DRUG Atazanavir
- DRUG Atazanavir/Cobicistat FDC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2013-04 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
What the finished NCT01837719 record still lists
NCT01837719 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Cobicistat is the first listed.
NCT01837719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01837719 about?
NCT01837719 is a clinical study titled "Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat". The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.
What is the current status of trial NCT01837719?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2013-04. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01837719?
The interventions under investigation include: Cobicistat (DRUG), Atazanavir (DRUG), Atazanavir/Cobicistat FDC (DRUG).
Who is sponsoring clinical trial NCT01837719?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01837719's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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