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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Iberdomide

• Registration Number: NCT05899738
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-17
• Study Start: 2023-05-18
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-12
• Primary Completion: 2023-07-06
• Study Completion: 2023-07-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Iberdomide Powder (Fasted), followed by Iberdomide Capsule (Fasted)	Iberdomide	-
Iberdomide Capsule (Fasted), followed by Iberdomide Powder (Fasted)	Iberdomide	-
Iberdomide Powder (Fasted), followed by Iberdomide Powder (Fed)	Iberdomide	-
Iberdomide Powder (Fed), followed by Iberdomide Powder (Fasted)	Iberdomide	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 Physical Examination Abnormalities	Up to 20 days
Number of Participants with Electrocardiogram Abnormalities	Up to 20 days

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 Daytona Beach, Florida, United States