Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin
NCT03131973 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2017-12-15
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.
Conditions
Interventions
- DRUG
-
BMS-986195
Specified dose on specified days
- DRUG
-
Methotrexate
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Caffeine
Specified dose on specified days
- DRUG
-
Montelukast
Specified dose on specified days
- DRUG
-
Flurbiprofen
Specified dose on specified days
- DRUG
-
Omeprazole
Specified dose on specified days
- DRUG
-
Midazolam
Specified dose on specified days
- DRUG
-
Digoxin
Specified dose on specified days
- DRUG
-
Pravastatin
Specified dose on specified days
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-05-13
- Primary Completion
- 2017-11-05
- Completion
- 2017-11-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
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