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A Study to Assess the Effects...

A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine

NCT ID: NCT05445440

Last Updated: 2023-02-08

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-06

Study Completion Date

2022-11-23

Brief Summary

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The purpose of this study is to evaluate the effects of BMS-986371 on the drug levels of methotrexate, sulfasalazine and their main metabolites in healthy male adult participants.

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Detailed Description

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This study will allow investigation of potential drug-drug interaction mediated through drug transporter proteins. During each part, blood samples will be collected at prespecified times for pharmacokinetic assessments. Subject safety will be monitored throughout the study. There will be approximately 16 subjects enrolled into each part.

Conditions

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Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

Specified dose on specified days

Leucovorin

Intervention Type DRUG

Specified dose on specified days

BMS-986371

Intervention Type DRUG

Specified dose on specified days

Part 2

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

Specified dose on specified days

Leucovorin

Intervention Type DRUG

Specified dose on specified days

BMS-986371

Intervention Type DRUG

Specified dose on specified days

Sulfasalazine

Intervention Type DRUG

Specified dose on specified days

Interventions

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Methotrexate

Specified dose on specified days

Intervention Type DRUG

Leucovorin

Specified dose on specified days

Intervention Type DRUG

BMS-986371

Specified dose on specified days

Intervention Type DRUG

Sulfasalazine

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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CC-99677

Eligibility Criteria

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Inclusion Criteria

* Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol
* Body mass index of 18 to 32 kg/m\^2, inclusive

Exclusion Criteria

* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect the absorption, distribution, metabolism and excretion of study drug
* Any other medical, psychiatric and/or social reason as determined by the Investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

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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Quotient Sciences Miami

Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/us/en/home.html

BMS Clinical Trial Patient Recruiting

Other Identifiers

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IM046-003

Identifier Type: -

Identifier Source: org_study_id

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