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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05899738
• Other study ID #: IM048-1038
• Status: Completed
• Phase: Phase 1
• Start date: May 18, 2023
• Est. completion date: July 6, 2023

Study information

• Verified date: August 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 6, 2023
• Est. primary completion date: July 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Iberdomide
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Daytona Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Number of Participants with Adverse Events		Up to 28 days
Secondary	Number of Participants with Vital Sign Abnormalities		Up to 20 days
Secondary	Number of Participants with Clinical Laboratory Abnormalities		Up to 20 days
Secondary	Number of Participants with Electrocardiogram Abnormalities		Up to 20 days
Secondary	Number of Participants with Physical Examination Abnormalities		Up to 20 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting