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

NCT05899738 | Completed Phase 1 FDA Drug

• 1 other identifier: IM048-1038
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy; Iberdomide; Bioavailability; Crossover; Powder Formulation; Food Effect; Fed; Fasted

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (4)

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

EXPERIMENTAL

Drug: Iberdomide

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

EXPERIMENTAL

Drug: Iberdomide

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

EXPERIMENTAL

Drug: Iberdomide

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

EXPERIMENTAL

Drug: Iberdomide

Interventions

Iberdomide DRUG

Specified dose on specified days

Also known as: BMS-986382, CC-220

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Celgene: collaborator

Study Sites (1)

Local Institution - 0001

Daytona Beach, Florida, 32117, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lecithin Cholesterol Acyltransferase Deficiency

Interventions

iberdomide

Condition Hierarchy (Ancestors)

Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 12, 2023
• Study Start: May 18, 2023
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)