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NCT03131973 · ClinicalTrials.gov registry record · Phase 1
Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03131973: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT03131973 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03131973, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Drug-drug interaction study in healthy men and women not of childbearing potential. Assess the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on safety of BMS-986195 and methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on multiple-dose pharmacodynamics of BMS-986195.
Primary Outcome
Measured by plasma concentrations
Interventions
- DRUG Leucovorin
- DRUG Montelukast
- DRUG Methotrexate
- DRUG Caffeine
- DRUG BMS-986195
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-05-13 |
| Est. Completion | 2017-11-10 |
| Phase | Phase 1 |
What the finished NCT03131973 record still lists
NCT03131973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 5 interventions - of which Leucovorin is the first listed.
NCT03131973 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03131973 about?
NCT03131973 is a clinical study titled "Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin". Drug-drug interaction study in healthy men and women not of childbearing potential. Assess the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on safety of BMS-986195 and methotrexate, ca...
What is the current status of trial NCT03131973?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2017-05-13. Estimated completion is 2017-11-10.
What interventions are being tested in trial NCT03131973?
The interventions under investigation include: Leucovorin (DRUG), Montelukast (DRUG), Methotrexate (DRUG), Caffeine (DRUG), BMS-986195 (DRUG).
Who is sponsoring clinical trial NCT03131973?
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 NCT03131973's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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