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

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05899738
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Iberdomide — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
May 18, 2023
Status verified
Jul 2024
Primary completion
Jul 6, 2023
Completion
Jul 6, 2023

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Iberdomide Powder (Fasted), followed by Iberdomide Capsule (Fasted)
  • Experimental: Iberdomide Capsule (Fasted), followed by Iberdomide Powder (Fasted)
  • Experimental: Iberdomide Powder (Fasted), followed by Iberdomide Powder (Fed)
  • Experimental: Iberdomide Powder (Fed), followed by Iberdomide Powder (Fasted)

Primary Outcome Measure

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Local Institution - 0001Daytona BeachFlorida32117-

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Local Institution - 0001· Daytona Beach, FL

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