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A Phase 1 Drug-drug Interaction Study in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

Effect of BMS-986020 on the Pharmacokinetics of Montelukast, Flurbiprofen, and Digoxin as Probe Substrates for CYP2C8, CYP2C9, and P-gp

NCT02227173•Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

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

San Antonio, Texas, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

November 1, 2014

Completion Date

November 1, 2014

Last Updated

November 18, 2014

Enrollment

ACTUAL participants

Conditions

Drug-drug Interaction Study

Interventions

BMS-986020

DRUG

Montelukast

DRUG

Flurbiprofen

DRUG

Digoxin

DRUG

Drug-drug Interaction Study of Rifampin and Anaprazole Sodium

NCT07330531

Drug-drug Interaction Study

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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