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NCT07242781

A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants

NCT ID: NCT07242781

Last Updated: 2025-12-24

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-06-14

Brief Summary

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The purpose of this study is to evaluate the effect of Itraconazole and Rifampin on the drug levels of AR-LDD (BMS-986365) in healthy adult male participants.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Healthy male volunteers BMS-986365 CC-94676 Itraconazole Rifampin Pharmacokinetics Crossover Open-label

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A (Safety Lead-in Group)

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Itraconazole

Intervention Type DRUG

Specified dose on specified days

Part A, Period 1

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Part A, Period 2

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Itraconazole

Intervention Type DRUG

Specified dose on specified days

Part B, Period 1

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Part B, Period 2

Group Type EXPERIMENTAL

BMS-986365

Intervention Type DRUG

Specified dose on specified days

Rifampin

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986365

Specified dose on specified days

Intervention Type DRUG

Itraconazole

Specified dose on specified days

Intervention Type DRUG

Rifampin

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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AR-LDD, CC-94676 SPORANOX®

Eligibility Criteria

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Inclusion Criteria

* Participants must be male, at the time of signing the Informed Consent Form (ICF), have a Body Mass Index (BMI) of 18.0 to 32.0 kg/m2; and healthy as determined by medical history, PE, vital signs, 12-lead ECG, transthoracic echocardiogram (TTE) and clinical laboratory assessments.

Exclusion Criteria

* Participants must not have any significant or chronic illness.
* Participants must not have a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Celgene

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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Syneos Health Clinic

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

Phone: 855-907-3286

Email: [email protected]

First line of the email MUST contain the NCT# and Site #.

Role: CONTACT

Facility Contacts

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David Wyatt, Site 0001

Role: primary

Related Links

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

BMS Clinical Trial Information

Other Identifiers

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CA071-1006

Identifier Type: -

Identifier Source: org_study_id