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

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
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PPD Development, LP
Austin, Texas 78744
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Austin, TX
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