Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 12/17/2017 |
Start Date: | May 13, 2017 |
End Date: | November 10, 2017 |
Effects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy Participants
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.
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.
Inclusion Criteria:
- Healthy male and female (not of childbearing potential) participants as determined by
medical and surgical history and assessments
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
- Normal kidney function at screening
Exclusion Criteria:
- History of chronic headaches (eg, migraines, cluster headaches), defined as occurring
15 days or more a month, over the previous 3 months
- History of headaches related to caffeine withdrawal, including energy drinks
- History of syncope, orthostatic instability, or recurrent dizziness
Other protocol defined inclusion and exclusion criteria could apply
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