NCT04933747

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Accepted

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%).

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Iberdomide	Administration of a single oral dose of 1mg iberdomide in participants
DRUG	Iberdomide	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

Timeline

• Start date: 2021-08-12
• Primary completion: 2023-01-23
• Completion: 2023-01-23
• First posted: 2021-06-22
• Last updated: 2023-02-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study