Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy
Iberdomide
Bioavailability
Crossover
Powder Formulation
Food Effect
Fed
Fasted
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Celgene
First posted: 2023-06-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 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)
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T))
timeFrame: 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)
measure: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF))
timeFrame: 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:
measure: Number of Participants with Adverse Events
timeFrame: Up to 28 days
measure: Number of Participants with Vital Sign Abnormalities
timeFrame: Up to 20 days
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to 20 days
measure: Number of Participants with Electrocardiogram Abnormalities
timeFrame: Up to 20 days
measure: Number of Participants with Physical Examination Abnormalities
timeFrame: Up to 20 days
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Local Institution - 0001
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: