CompletedPhase 1

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

United States32 participantsStarted 2023-05-18

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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)

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)

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)

Trial details

NCT IDNCT05899738

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-06

View on ClinicalTrials.gov More Healthy Volunteers trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

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)

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)