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A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

NCT ID: NCT02227173

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Drug-drug Interaction Study

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Single-Sequence, A B C

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

Group Type EXPERIMENTAL

BMS-986020

Intervention Type DRUG

Montelukast

Intervention Type DRUG

Flurbiprofen

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Interventions

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BMS-986020

Intervention Type DRUG

Montelukast

Intervention Type DRUG

Flurbiprofen

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emanuel DeNoia, MD

Role: PRINCIPAL_INVESTIGATOR

ICON Development Solutions

Locations

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

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IM136-004

Identifier Type: -

Identifier Source: org_study_id