Study to Evaluate Safety and Tolerability of Iberdomide (CC-220) in Participants With Kidney Impairment Compared to Participants With Normal Kidney Function

Part of paid clinical trials in Orlando, Florida.

Sponsor
Celgene
Study ID
NCT04933747
Phase
PHASE1
Status
Completed

Conditions

  • Renal Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 82 Years
Healthy Volunteers
Accepted

Interventions

  • Iberdomide — DRUG
    Administration of a single oral dose of 1mg iberdomide in participants
  • Iberdomide — DRUG
    Administration of a single oral dose of 1mg iberdomide in participants on 2 occasions - once on a dialysis day and once on a non-dialysis day

Study Details

This is an open-label study of iberdomide in participants with severe renal impairment or participants receiving dialysis compared to participants with normal renal function. An open-label design was selected based on the objective nature of the primary endpoints (i.e., Pharmacokinetics parameter estimates based on measurement of iberdomide and M12 concentrations). Participants with severe renal impairment (RI), participants with kidney failure on intermittent hemodialysis (IHD), and participants with normal renal function are being included in the current study. Participants with severe RI and kidney failure participants will be matched to participants with normal renal function based on sex, age (approximately ± 10 years), and body mass index (BMI; approximately ± 30%).

Key Dates

Start date
Aug 12, 2021
Status verified
Feb 2023
Primary completion
Jan 23, 2023
Completion
Jan 23, 2023

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Participants with severe Renal Impairment (RI)
    Severe Renal Impairment (RI), as defined by an eGFR \< 30 mL/min/1.73 m2 and not requiring dialysis, at screening
  • Experimental: Group 2: Participants with kidney failure who are on intermittent hemodialysis (IHD)
    Kidney failure participants on intermittent hemodialysis (IHD)
  • Experimental: Group 3: Participants with normal renal function
    Normal renal function, as defined by a creatinine clearance (Clcr) \> 90 mL/min estimated using the Cockcroft-Gault (C-G) equation, at screening.

Primary Outcome Measure

Iberdomide Pharmacokinetics - AUC(0-T) [ Time Frame: Up to 72 hours following the last dose of iberdomide ]

Locations (3)

FacilityCityStateZIPSite coordinators
Local Institution - 001OrlandoFlorida32809-
Local Institution - 002KnoxvilleTennessee37920-
Local Institution - 003San AntonioTexas78215-

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By research site
Local Institution - 001· Orlando, FLLocal Institution - 002· Knoxville, TNLocal Institution - 003· San Antonio, TX

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