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

Study Overview
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Iberdomide


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iberdomide Powder (Fasted), followed by Iberdomide Capsule (Fasted)<br> | Drug: Iberdomide<br>* Specified dose on specified days<br>* Other names: CC-220;|
| Experimental: Iberdomide Capsule (Fasted), followed by Iberdomide Powder (Fasted)<br> | Drug: Iberdomide<br>* Specified dose on specified days<br>* Other names: CC-220;|
| Experimental: Iberdomide Powder (Fasted), followed by Iberdomide Powder (Fed)<br> | Drug: Iberdomide<br>* Specified dose on specified days<br>* Other names: CC-220;|
| Experimental: Iberdomide Powder (Fed), followed by Iberdomide Powder (Fasted)<br> | Drug: Iberdomide<br>* Specified dose on specified days<br>* Other names: CC-220;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fed, Healthy, Iberdomide, Bioavailability, Crossover, Powder Formulation, Food Effect, Fasted