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%).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Administration of a single oral dose of 1mg iberdomide in participants
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
Local Institution - 001
Orlando, Florida, United States
Local Institution - 002
Knoxville, Tennessee, United States
Local Institution - 003
San Antonio, Texas, United States
Iberdomide Pharmacokinetics - AUC(0-T)
Estimation of area under the plasma concentration -time curve (AUC) calculated from time zero to time t, where t is the time point of the last measurable concentration
Time frame: Up to 72 hours following the last dose of iberdomide
Metabolite M12 Pharmacokinetics - AUC(0-T)
Estimation of AUC calculated from time zero to time t, where t is the time point of the last measurable concentration
Time frame: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - AUC(INF)
Estimation of AUC calculated from time zero extrapolated to infinity
Time frame: Up to 72 hours following the last dose of iberdomide
Metabolite M12 Pharmacokinetics - AUC(INF)
Estimation of AUC calculated from time zero extrapolated to infinity
Time frame: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - Cmax
Estimation of maximum observed plasma concentration
Time frame: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - Tmax
Estimated time to Cmax
Time frame: Up to 72 hours following the last dose of iberdomide
Metabolite M12 Pharmacokinetics - Tmax
Estimated time to Cmax
Time frame: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - T-HALF
Estimation of terminal elimination half-life in plasma
Time frame: Up to 72 hours following the last dose of iberdomide
Metabolite M12 Pharmacokinetics - T-HALF
Estimation of terminal elimination half-life in plasma
Time frame: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - CLT/F
Apparent total plasma clearance when dosed orally
Time frame: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - CLNR/F
Apparent nonrenal clearance
Time frame: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - VZ/F
Estimation of apparent volume of distribution when dosed orally
Time frame: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - CLR
Renal Clearance
Time frame: Up to 72 hours following the last dose of iberdomide
Metabolite M12 Pharmacokinetics - CLR
Renal clearance
Time frame: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - UR
Estimation of amount excreted in urine
Time frame: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - CLD
Dialysis clearance
Time frame: 4 hours post-start of dialysis
Incidence of Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values), regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE
Time frame: From enrollment until at least 28 days after completion of the study treatment
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