A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)

NCT ID: NCT04468815

Last Updated: 2022-05-10

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-10

Study Completion Date

2020-10-07

Brief Summary

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The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A: BMS-986278 suspension, fasted

Group Type EXPERIMENTAL

BMS-986278 suspension

Intervention Type DRUG

Specified dose on specified days

Treatment B: BMS-986278 tablet, fasted

Group Type EXPERIMENTAL

BMS-986278 Tablet

Intervention Type DRUG

Specified dose on specified days

Treatment C: BMS-986278 tablet, fed

Group Type EXPERIMENTAL

BMS-986278 Tablet

Intervention Type DRUG

Specified dose on specified days

Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted

Group Type EXPERIMENTAL

BMS-986278 Tablet

Intervention Type DRUG

Specified dose on specified days

Esomeprazole

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986278 Tablet

Specified dose on specified days

Intervention Type DRUG

Esomeprazole

Specified dose on specified days

Intervention Type DRUG

BMS-986278 suspension

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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NEXIUM

Eligibility Criteria

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Inclusion Criteria

* Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
* Women and men must agree to follow specific methods of contraception

Exclusion Criteria

* Women of childbearing potential (WOCBP) and Women who are pregnant 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
* Exposure to any investigational drug or placebo within 4 weeks of first study treatment administration.
* History of any significant drug and/or food allergies (such as anaphylaxis or hepatotoxicity)
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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ICON (LPRA) - Salt Lake

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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IM027-054

Identifier Type: -

Identifier Source: org_study_id

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