Study to Evaluate the Effect of Rifampin on the Drug Levels in Blood and Safety of BMS-986235 in Healthy Participants

NCT ID: NCT04301310

Last Updated: 2022-03-31

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2020-03-16

Brief Summary

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The purpose of this study is to examine the effect of rifampin on the drug levels in blood and safety of BMS-986235, when taken by 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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Treatment Group

Group Type EXPERIMENTAL

BMS-986235 (Treatment A)

Intervention Type DRUG

Specified dose on specified days

Rifampin (Treatment B)

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986235 (Treatment A)

Specified dose on specified days

Intervention Type DRUG

Rifampin (Treatment B)

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations; no significant findings in medical history.
* Body mass index of 18.0 kg/m2 to 30.0 kg/m2, inclusive, at screening
* Males must agree to follow specific methods of contraception, if applicable

Exclusion Criteria

* Women of childbearing potential (WOCBP)
* Known previous exposure to BMS-986235
* History of any significant drug allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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Local Institution

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV018-023

Identifier Type: -

Identifier Source: org_study_id

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