Effects of BMS-986142 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates Montelukast (CYP2C8), Flurbiprofen (CYP2C9), Midazolam (CYP3A4), Digoxin (P-gp), and Pravastatin (OATP1B1) in Healthy Subjects

NCT02456844 Phase 1 COMPLETED

To study the Pharmacokinetics (PK) parameters of montelukast, flurbiprofen, midazolam, digoxin, pravastatin, and MTX when coadministered with BMS-986142.

Details

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	COMPLETED
Enrolment	24
Start date	2015-05
Completion	2015-07

Conditions

• Rheumatoid Arthritis

Interventions

• Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142
• Methotrexate, Leucovorin and BMS-986142

Primary outcomes

• Maximum observed plasma concentration (Cmax) — Days 1 through 10
• Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration, AUC(0-T) — Days 1 through 10
• Area under the plasma concentration-time curve from time zero extrapolated to infinite time, AUC(INF) — Days 1 through 10