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Completed

NCT Number: NCT05899738

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

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.

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Key information

Conditions

Healthy Volunteers Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hypoalphalipoproteinemias Hypolipoproteinemias Lecithin Cholesterol Acyltransferase Deficiency Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iberdomide

Drug

Specified dose on specified days

Other names: BMS-986382, CC-220

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 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)

  2. Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T))

    Time frame: 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)

  3. Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF))

    Time frame: 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

  1. Number of Participants with Adverse Events

    Time frame: Up to 28 days

  2. Number of Participants with Vital Sign Abnormalities

    Time frame: Up to 20 days

  3. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Up to 20 days

  4. Number of Participants with Electrocardiogram Abnormalities

    Time frame: Up to 20 days

  5. Number of Participants with Physical Examination Abnormalities

    Time frame: Up to 20 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Celgene

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2023
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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