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NCT01766050 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers
A Phase 4 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
NCT01766050: Completed Phase 4 study, sponsored by Bristol-Myers Squibb.
NCT01766050 is a Phase 4 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 45 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01766050, a Phase 4 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effects of belatacept on the pharmacokinetics of caffeine, losartan, omeprazole, dextromethorphan and midazolam
Primary Outcome
Samples for the assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for midazolam with and without
Interventions
- DRUG Midazolam
- DRUG Losartan
- DRUG Omeprazole
- DRUG Caffeine
- DRUG Dextromethorphan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-04 |
| Phase | Phase 4 |
What the finished NCT01766050 record still lists
NCT01766050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which Midazolam is the first listed.
NCT01766050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01766050 about?
NCT01766050 is a clinical study titled "Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers". The purpose of this study is to determine the effects of belatacept on the pharmacokinetics of caffeine, losartan, omeprazole, dextromethorphan and midazolam
What is the current status of trial NCT01766050?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 2013-01. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01766050?
The interventions under investigation include: Midazolam (DRUG), Losartan (DRUG), Omeprazole (DRUG), Caffeine (DRUG), Dextromethorphan (DRUG).
Who is sponsoring clinical trial NCT01766050?
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 NCT01766050's enrollment target sits among peer trials
45 1354th of 2000 higher than 638 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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