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A Study to Assess the Drug Le...

A Study to Assess the Drug Levels of CC-92480 After Coadministration With Rifampin and Itraconazole, and the Drug Levels of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants

NCT ID: NCT05389722

Last Updated: 2023-04-19

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2022-11-12

Brief Summary

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The purpose of this study is to evaluate the drug levels of CC-92480 after coadministration with rifampin and itraconazole and the drug levels of digoxin and rosuvastatin after coadministration with CC-92480 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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Rifampin

Intervention Type DRUG

Specified dose on specified days

Part 2

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Itraconazole

Intervention Type DRUG

Specified dose on specified days

Part 3

Group Type EXPERIMENTAL

CC-92480

Intervention Type DRUG

Specified dose on specified days

Digoxin

Intervention Type DRUG

Specified dose on specified days

Rosuvastatin

Intervention Type DRUG

Specified dose on specified days

Interventions

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CC-92480

Specified dose on specified days

Intervention Type DRUG

Rifampin

Specified dose on specified days

Intervention Type DRUG

Itraconazole

Specified dose on specified days

Intervention Type DRUG

Digoxin

Specified dose on specified days

Intervention Type DRUG

Rosuvastatin

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986348

Eligibility Criteria

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Inclusion Criteria

* Must have a body mass index between 18 and 33 kg/m2 (inclusive)
* Adult female of nonchildbearing potential or male, any race or ethnicity, and in good health as determined by the medical history, physical exam, vital signs, 12-lead electrocardiogram, and clinical laboratory assessments

Exclusion Criteria

* Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion
* Any major surgery within 4 weeks of the first dose administration
* History of drug abuse within 2 years of the first dose administration

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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Covance Clinical Research Unit - Dallas

Dallas, Texas, 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.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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CA057-002

Identifier Type: -

Identifier Source: org_study_id

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