A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

Bristol-Myers Squibb20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Drug-drug Interaction Study

Interventions

BMS-986020DRUG

MontelukastDRUG

FlurbiprofenDRUG

DigoxinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Healthcare Discoveries, LLC d/b/a ICON Development Solutions

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Pharmacokinetic parameters (maximum observed plasma concentration, area under the concentration-time curve) for montelukast, flurbiprofen, and digoxin

Pharmacokinetic endpoints for montelukast, flurbiprofen, and digoxin with and without BMS-986020

Time frame: Predose and up to 168 hours post dose

Secondary Outcomes

Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin.

Additional pharmacokinetic parameters for montelukast, flurbiprofen, digoxin, and with and without BMS-986020

Time frame: Predose and up to 168 hour post dose

Safety

Collection of adverse events and other physical parameters to assess safety

Time frame: From dosing (Day 1) to Day 21

Data from ClinicalTrials.gov

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