A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Digoxin; Flurbiprofen; Montelukast

Criteria

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