A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

Completed · Phase 1

Conditions studied: Drug-drug Interaction Study

In brief

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.

Key facts

Study ID

NCT02227173

Run by

Bristol-Myers Squibb

People needed

20

Starts

2014-09-01

Expected to finish

2014-11-01

Last updated by the study team

2014-11-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Healthcare Discoveries, LLC d/b/a ICON Development Solutions — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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