A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants

NCT ID: NCT04941755

Last Updated: 2022-01-21

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-25

Study Completion Date

2021-09-24

Brief Summary

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The purpose of this study is to investigate the effect of gastric pH changes induced by famotidine on the drug levels of BMS-986256.

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

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sequence AB

Group Type EXPERIMENTAL

BMS-986256

Intervention Type DRUG

Specified dose on specified days

Famotidine

Intervention Type DRUG

Specified dose on specified days

Sequence BA

Group Type EXPERIMENTAL

BMS-986256

Intervention Type DRUG

Specified dose on specified days

Famotidine

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986256

Specified dose on specified days

Intervention Type DRUG

Famotidine

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Pepcid

Eligibility Criteria

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Inclusion Criteria

* Healthy participants, defined as having no clinically significant deviations from normal in medical history
* Weight ≥ 50 kg and body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive, at screening
* Normal renal function at screening

Exclusion Criteria

* Any significant acute or chronic medical illness
* Current or recent gastrointestinal (GI) disease that could impact upon the absorption of study treatment
* Any major surgery within 4 weeks of study treatment administration
* Significant history of GI abnormalities
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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PPD Development, LP

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM026-029

Identifier Type: -

Identifier Source: org_study_id

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