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

July 25, 2024 updated by: Bristol-Myers Squibb

A Phase 1, Open-Label, Randomized, Two-Part, Two-Period, Two-Sequence Crossover Study to Assess the Relative Bioavailability of Iberdomide (CC-220) Powder for Reconstitution Formulation to the Reference Capsule Formulation and to Assess the Effect of Food on the Pharmacokinetics of Powder for Reconstitution Formulation in Healthy Adult Participants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iberdomide Powder (Fasted), followed by Iberdomide Capsule (Fasted)
Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Experimental: Iberdomide Capsule (Fasted), followed by Iberdomide Powder (Fasted)
Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Experimental: Iberdomide Powder (Fasted), followed by Iberdomide Powder (Fed)
Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382
Experimental: Iberdomide Powder (Fed), followed by Iberdomide Powder (Fasted)
Drug: Iberdomide
Specified dose on specified days
Other Names:
  • CC-220
  • BMS-986382

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)
Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)
Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T))
Time Frame: Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)
Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF))
Time Frame: Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)
Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events
Time Frame: Up to 28 days
Up to 28 days
Number of Participants with Vital Sign Abnormalities
Time Frame: Up to 20 days
Up to 20 days
Number of Participants with Clinical Laboratory Abnormalities
Time Frame: Up to 20 days
Up to 20 days
Number of Participants with Electrocardiogram Abnormalities
Time Frame: Up to 20 days
Up to 20 days
Number of Participants with Physical Examination Abnormalities
Time Frame: Up to 20 days
Up to 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2023

Primary Completion (Actual)

July 6, 2023

Study Completion (Actual)

July 6, 2023

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IM048-1038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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