A Phase 1 Drug-drug Interaction Study in Healthy Volunteers
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 11/8/2014 |
| Start Date: | September 2014 |
| Contact: | Call Center |
| Phone: | 210-225-4537 |
Effect of BMS-986020 on the Pharmacokinetics of Montelukast, Flurbiprofen, and Digoxin as Probe Substrates for CYP2C8, CYP2C9, and P-gp
This is an open-label, single-sequence, drug-drug interaction study in healthy male and
female subjects. There is no formal research hypothesis to be statistically tested. It is
expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may
increase the exposure of montelukast, flurbiprofen, and digoxin.
female subjects. There is no formal research hypothesis to be statistically tested. It is
expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may
increase the exposure of montelukast, flurbiprofen, and digoxin.
Inclusion Criteria:
- Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive, with a
body mass index of 18.0 to 32.0 kg/m2, inclusive
- Women of childbearing potential must agree to follow instructions for methods of
contraception for the duration of the study
Exclusion Criteria:
- Any significant acute or chronic medical illness
- History of arrhythmias or palpitations associated with dizziness or fainting
- History of clinically relevant cardiac disease
Other protocol defined exclusion criteria could apply
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