An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants

NCT ID: NCT03712540

Last Updated: 2019-06-12

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-06

Study Completion Date

2018-11-08

Brief Summary

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The purpose of this study is to investigate the effects of experimental medication BMS-986278 given with the antibiotic Rifampin in healthy participants.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-986278 + Rifampin

Treatment period A: BMS-986278 alone Treatment period B: Rifampin followed by BMS-986278

Group Type EXPERIMENTAL

BMS-986278

Intervention Type DRUG

Oral administration 30 mg

Rifampin

Intervention Type DRUG

Oral administration 600 mg

Interventions

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BMS-986278

Oral administration 30 mg

Intervention Type DRUG

Rifampin

Oral administration 600 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening

Exclusion Criteria

* Women who are of childbearing potential or breastfeeding
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
* History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
* History of significant cardiovascular disease
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 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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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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PRA Health Science KK

Lenexa, Kansas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM027-017

Identifier Type: -

Identifier Source: org_study_id

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