Healthy Volunteers
Conditions
Keywords
Healthy, Iberdomide, Bioavailability, Crossover, Powder Formulation, Food Effect, Fed, Fasted
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.
Interventions
DRUGIberdomide
Specified dose on specified days
Sponsors
Celgene
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of Participants with Electrocardiogram Abnormalities | Up to 20 days |
| Number of Participants with Adverse Events | Up to 28 days |
| Number of Participants with Physical Examination Abnormalities | Up to 20 days |
| Number of Participants with Vital Sign Abnormalities | Up to 20 days |
| Number of Participants with Clinical Laboratory Abnormalities | Up to 20 days |
Countries
United States
Outcome results
None listed