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A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235

NCT ID: NCT04464577

Last Updated: 2022-03-25

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WITHDRAWN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

2021-04-01

Study Completion Date

2021-06-08

Brief Summary

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This study will evaluate the effect of inhibitors, at steady state, on the drug levels, safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to be utilized in this study are fluconazole, bupropion, and itraconazole.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: BMS-986235+Fluconazole

Group Type EXPERIMENTAL

Fluconazole

Intervention Type DRUG

Specified Dose on Specified Days

BMS-986235

Intervention Type DRUG

Specified Dose on Specified Days

Arm B: BMS-986235+ Bupropion

Group Type EXPERIMENTAL

Bupropion

Intervention Type DRUG

Specified Dose on Specified Days

BMS-986235

Intervention Type DRUG

Specified Dose on Specified Days

Arm C: BMS-986235+ Itraconazole

Group Type EXPERIMENTAL

Itraconazole

Intervention Type DRUG

Specified Dose on Specified Days

BMS-986235

Intervention Type DRUG

Specified Dose on Specified Days

Interventions

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Fluconazole

Specified Dose on Specified Days

Intervention Type DRUG

Bupropion

Specified Dose on Specified Days

Intervention Type DRUG

Itraconazole

Specified Dose on Specified Days

Intervention Type DRUG

BMS-986235

Specified Dose on Specified Days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
* Males and females must agree to follow specific methods of contraception, if applicable.
* Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations, and no significant findings in medical history.

Exclusion Criteria

* Women of childbearing potential (WOCBP), women who are pregnant or breastfeeding
* Inability to tolerate oral medication
* Known previous exposure to BMS-986235.
Minimum Eligible Age

18 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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Local Institution

Lenexa, Kansas, United States

Site Status

Local Institution

Salt Lake City, Utah, 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

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

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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CV018-014

Identifier Type: -

Identifier Source: org_study_id

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