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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Iberdomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05899738

IM048-1038

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

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

Experimental group

Treatment:

Drug: Iberdomide

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

Experimental group

Treatment:

Drug: Iberdomide

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

Experimental group

Treatment:

Drug: Iberdomide

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

Experimental group

Treatment:

Drug: Iberdomide