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

A Phase 1, Open-label, Multicenter Study to Evaluate the Pharmacokinetics of Iberdomide (CC-220) in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04933747
Enrollment
26
Registered
2021-06-22
Start date
2021-08-12
Completion date
2023-01-23
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency

Keywords

Renal Insufficiency, CC-220, Iberdomide, Phase 1

Brief summary

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%).

Interventions

DRUGIberdomide

Administration of a single oral dose of 1mg iberdomide in participants

Sponsors

Celgene
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion Criteria for All Participants (All Groups) Participants must satisfy the following criteria to be enrolled in the study: 1. Participant is ≥ 18 and ≤ 82 years of age at the time of signing the informed consent form (ICF). 2. Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. 3. Participant is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions, the study visit schedule, and other protocol requirements, including contraception requirements. 4. Participant has a body mass index (BMI) ≥ 18 and ≤ 40 kg/m2 at screening. 5. Participant has a body weight \> 50 kg at screening. 6. Participant is afebrile (febrile is defined as ≥ 38°C or 100.4°F). Inclusion Criteria for Participants with Severe Renal Impairment (RI) - Group 1 Participants in Group 1 must also satisfy the following criteria to be enrolled in the study: 7. Participant has a supine systolic blood pressure (BP) ≥ 90 and ≤ 180 mm Hg, supine diastolic BP ≥ 60 and ≤ 110 mm Hg, and pulse rate ≥ 40 and ≤ 110 beats per minute. 8. Participant has severe renal impairment as defined by an eGFR \< 30 mL/min/1.73 m2 (and not requiring dialysis) at screening. The eGFR will be calculated using the Modification of Diet in Renal Disease (MDRD) equation. 9. Participant must be medically stable for at least 1 month before the first IP administration with a clinically acceptable medical history, physical examination (PE), clinical laboratory safety test results, vital sign measurements, and 12-lead electrocardiograms (ECGs) consistent with the underlying stable RI condition, as judged by the Investigator. a. Participant must have a QTcF value \< 480 ms. 10. Participant must be stable in concomitant medication regimen (defined as not starting a new medication\[s\] or a change in the dosage or frequency of the concomitant medication\[s\] within 7 days or 5 half-lives \[whichever is longer\] before the first IP administration). Inclusion Criteria for Participants with Kidney Failure on IHD - Group 2 Participants in Group 2 must also satisfy the following criteria to be enrolled in the study: 11. Participant has a pulse rate ≥ 40 and ≤ 110 beats per minute. Blood pressure measurements must be consistent with the participant's underlying medical condition(s) and judged by the Investigator as being clinically acceptable for purposes of study entry. 12. Participant must be medically stable for at least 1 month before the first IP administration with a clinically acceptable medical history, PE, clinical laboratory safety test results, vital sign measurements, and 12-lead ECGs consistent with the underlying kidney failure, as judged by the Investigator. 13. Participant must be stable in concomitant medication regimen 14. Participant has been attending an average of 3 hemodialysis treatments per week within the 3 months prior to screening. Inclusion Criteria for Participants with Normal Renal Function -Group 3 15. Participant has a supine systolic BP ≥ 90 and ≤ 160 mm Hg, supine diastolic BP ≥ 50 and ≤ 100 mm Hg, and pulse rate ≥ 40 and ≤ 100 beats per minute. 16. Participant is in good health, as determined by past medical history, PE, vital signs, 12-lead ECG, and clinical laboratory safety test results, and has normal renal function, as defined by having a Clcr \> 90 mL/min estimated using the C-G equation, at screening. 1. If male, participant has a QTcF value \< 470 ms; 2. If female, participant has a QTcF value \< 480 ms. 17. Participant must match at least 1 participant in Groups 1 or 2 with respect to sex, age (approximately ± 10 years), and BMI (approximately ± 30%).

Design outcomes

Primary

MeasureTime frameDescription
Iberdomide Pharmacokinetics - CLD4 hours post-start of dialysisDialysis clearance
Iberdomide Pharmacokinetics - AUC(0-T)Up to 72 hours following the last dose of iberdomideEstimation 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
Metabolite M12 Pharmacokinetics - AUC(0-T)Up to 72 hours following the last dose of iberdomideEstimation of AUC calculated from time zero to time t, where t is the time point of the last measurable concentration
Iberdomide Pharmacokinetics - AUC(INF)Up to 72 hours following the last dose of iberdomideEstimation of AUC calculated from time zero extrapolated to infinity
Metabolite M12 Pharmacokinetics - AUC(INF)Up to 72 hours following the last dose of iberdomideEstimation of AUC calculated from time zero extrapolated to infinity
Iberdomide Pharmacokinetics - CmaxUp to 72 hours following the last dose of iberdomideEstimation of maximum observed plasma concentration
Iberdomide Pharmacokinetics - TmaxUp to 72 hours following the last dose of iberdomideEstimated time to Cmax
Metabolite M12 Pharmacokinetics - TmaxUp to 72 hours following the last dose of iberdomideEstimated time to Cmax
Iberdomide Pharmacokinetics - T-HALFUp to 72 hours following the last dose of iberdomideEstimation of terminal elimination half-life in plasma
Metabolite M12 Pharmacokinetics - T-HALFUp to 72 hours following the last dose of iberdomideEstimation of terminal elimination half-life in plasma
Iberdomide Pharmacokinetics - CLT/FUp to 72 hours following the last dose of iberdomideApparent total plasma clearance when dosed orally
Iberdomide Pharmacokinetics - CLNR/FUp to 72 hours following the last dose of iberdomideApparent nonrenal clearance
Iberdomide Pharmacokinetics - VZ/FUp to 72 hours following the last dose of iberdomideEstimation of apparent volume of distribution when dosed orally
Iberdomide Pharmacokinetics - CLRUp to 72 hours following the last dose of iberdomideRenal Clearance
Metabolite M12 Pharmacokinetics - CLRUp to 72 hours following the last dose of iberdomideRenal clearance
Iberdomide Pharmacokinetics - URUp to 72 hours following the last dose of iberdomideEstimation of amount excreted in urine

Secondary

MeasureTime frameDescription
Incidence of Adverse Events (AEs)From enrollment until at least 28 days after completion of the study treatmentAn 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026