A Study to Compare the Relative Bioavailability of Two Iberdomide (CC-220) Formulations and to Assess The Effect Of Food on the Drug Levels of Iberdomide in Healthy Adult Participants

NCT ID: NCT05899738

Last Updated: 2024-07-26

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-18

Study Completion Date

2023-07-06

Brief Summary

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The purpose of this study is to evaluate the relative bioavailability for the new iberdomide powder for reconstitution formulation relative to the reference capsule formulation and to assess the effect of food on the pharmacokinetics of powder for reconstitution formulation in healthy adult participants.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iberdomide Powder (Fasted), followed by Iberdomide Capsule (Fasted)

Group Type EXPERIMENTAL

Iberdomide

Intervention Type DRUG

Specified dose on specified days

Iberdomide Capsule (Fasted), followed by Iberdomide Powder (Fasted)

Group Type EXPERIMENTAL

Iberdomide

Intervention Type DRUG

Specified dose on specified days

Iberdomide Powder (Fasted), followed by Iberdomide Powder (Fed)

Group Type EXPERIMENTAL

Iberdomide

Intervention Type DRUG

Specified dose on specified days

Iberdomide Powder (Fed), followed by Iberdomide Powder (Fasted)

Group Type EXPERIMENTAL

Iberdomide

Intervention Type DRUG

Specified dose on specified days

Interventions

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Iberdomide

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986382 CC-220

Eligibility Criteria

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Inclusion Criteria

* Body mass index of 18.0 to 33.0 kilograms (kg)/square meter, inclusive, and body weight ≥50 kg.
* A female participant is eligible to participate if she is not of childbearing potential as defined in the protocol.
* Males who are sexually active with woman of childbearing potential must agree to follow instructions for method(s) of contraception as described in the protocol and included in the informed consent form.
* Male participants are required to use a condom and must refrain from donating sperm during the intervention period and for at least 28 days after the last dose of study intervention.

Exclusion Criteria

* Any significant acute or chronic medical illness.
* Current or recent (within 3 months of the first dose of the investigational medicinal product) gastrointestinal disease or procedure that could possibly affect drug absorption, distribution, metabolism, and excretion (for example, bariatric procedure).
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram, or clinical laboratory determinations.
* Female who are of childbearing potential and females who are breastfeeding.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celgene

INDUSTRY

Sponsor Role collaborator

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 - 0001

Daytona Beach, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM048-1038

Identifier Type: -

Identifier Source: org_study_id

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