A Phase 1 Drug-drug Interaction Study in Healthy Volunteers (DDI)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Drug-drug Interaction Study

Treatments: Drug: BMS-986020; Drug: Montelukast; Drug: Digoxin; Drug: Flurbiprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT02227173

IM136-004

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Single-Sequence, A B C

Experimental group

Description:

Treatment A: Single oral dose of montelukast, flurbiprofen, and digoxin on Day 1 Treatment B: BMS-986020 orally twice daily (BID) on Day 8 through Day 10 Treatment C: BMS-986020 orally BID, single oral dose of montelukast, flurbiprofen, and digoxin on Day 11; BMS-986020 BID on Day 12 through Day 17

Treatment:

Drug: Flurbiprofen

Drug: Montelukast

Drug: Digoxin

Drug: BMS-986020