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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05899738

Collaborator

Celgene (Industry)

Enrollment

Location

Arms

1.7

Anticipated Duration (Months)

18.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Iberdomide	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 18, 2023

Anticipated Primary Completion Date :

Jul 10, 2023

Anticipated Study Completion Date :

Jul 10, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) [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)) [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)) [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

Number of Participants with Adverse Events [Up to 28 days]
Number of Participants with Vital Sign Abnormalities [Up to 20 days]
Number of Participants with Clinical Laboratory Abnormalities [Up to 20 days]
Number of Participants with Electrocardiogram Abnormalities [Up to 20 days]
Number of Participants with Physical Examination Abnormalities [Up to 20 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.