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NCT01585623 · ClinicalTrials.gov registry record · Phase 1
Drug Interaction Study of SAR302503 in Patients With Solid Tumor
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01585623: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT01585623 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01585623, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Primary Objective: * To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4). * To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses. Secondary Objectives: * To assess the safety profile of 15-day repeated oral doses of 500 mg SAR302503 in Segment 1 * To characterize the safety and tolerability of 28-day consecutive doses of 500 mg SAR302503 in Segment 2 * To determine antitumor activity in Segment 2
Interventions
- DRUG midazolam
- DRUG metoprolol
- DRUG SAR302503
- DRUG omeprazol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT01585623 record still lists
NCT01585623 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which midazolam is the first listed.
NCT01585623 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01585623 about?
NCT01585623 is a clinical study titled "Drug Interaction Study of SAR302503 in Patients With Solid Tumor". Primary Objective: * To assess the effect of 15-day repeated oral doses of 500 mg SAR302503 on the cytochrome P450 activity using a CYP probe cocktail (2C19, 2D6 and 3A4). * To document pharmacokinetics of SAR302503 after repeated 500 mg oral daily doses. Secondary Objectives: * To assess the saf...
What is the current status of trial NCT01585623?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2012-06. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01585623?
The interventions under investigation include: midazolam (DRUG), metoprolol (DRUG), SAR302503 (DRUG), omeprazol (DRUG).
Who is sponsoring clinical trial NCT01585623?
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 NCT01585623's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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