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A Study to Assess the Effect ...

A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants

NCT ID: NCT05932277

Last Updated: 2023-10-30

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

2023-06-29

Study Completion Date

2023-09-13

Brief Summary

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The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy participants.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cocktail Probe Substrates + BMS-986419

Group Type EXPERIMENTAL

BMS-986419

Intervention Type DRUG

Specified dose on specified days

Caffeine

Intervention Type DRUG

Specified dose on specified days

Bupropion

Intervention Type DRUG

Specified dose on specified days

Flurbiprofen

Intervention Type DRUG

Specified dose on specified days

Omeprazole

Intervention Type DRUG

Specified dose on specified days

Midazolam

Intervention Type DRUG

Specified dose on specified days

Fexofenadine

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986419

Specified dose on specified days

Intervention Type DRUG

Caffeine

Specified dose on specified days

Intervention Type DRUG

Bupropion

Specified dose on specified days

Intervention Type DRUG

Flurbiprofen

Specified dose on specified days

Intervention Type DRUG

Omeprazole

Specified dose on specified days

Intervention Type DRUG

Midazolam

Specified dose on specified days

Intervention Type DRUG

Fexofenadine

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in (Day -1).
* Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg. BMI may be rounded.

Exclusion Criteria

* Any significant acute or chronic medical conditions or any significant acute or chronic medical illness as determined by the investigator
* Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention

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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ICON Lenexa

Lenexa, Kansas, 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/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

Other Identifiers

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CN007-1000

Identifier Type: -

Identifier Source: org_study_id

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