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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 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 16 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01585623
The ClinicalTrials.gov registry entry for NCT01585623 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which midazolam is the first listed.
NCT01585623 reports 0 study locations.
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.
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