NCT03097016

A Study to Assess the Pharmacokinetics of CC-122 in Subjects With Mild, Moderate, and Severe Renal Impairment

A Phase 1, Open-label, Single-dose Study to Assess the Pharmacokinetics (PK) of CC-122 in Subjects With Mild, Moderate and Severe Renal Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age (± 15 years), and weight (± 20%) matched control subjects with normal renal function.

Detailed description

This will be a multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age (± 15 years), and weight (± 20%) matched control subjects with normal renal function. Estimated renal function for the purpose of group assignment will be determined at screening. Matched control subjects will have normal renal function, defined using the Cockcroft-Gault (C G) equation, as an estimated creatinine clearance (CLcr) of ≥ 90 mL/min. Subjects with impaired renal function will be classified by stage of renal impairment (mild, moderate, or severe) using estimated glomerular filtration rate (eGFR), calculated by the Modification of Diet in Renal Disease (MDRD) equation. Each group will enroll at least 2 subjects of each sex During the course of the study, each subject will participate in a Screening period (Days - 21 to -2), Treatment Period (including baseline visit), and a follow-up telephone call between Days 11 to 18. Subjects will be screened for eligibility. Eligible subjects will return to the clinical site on Day 1 for baseline assessments, and will be domiciled at the clinical site from Day 1 to Day 4. PK samples will be collected through 72 hours post dose. Safety will be monitored throughout study. The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	CC-122	All subjects will receive one 3 mg CC-122 capsule the morning of Day 1 which will be administered in the fasted state.

Timeline

• Start date: 2017-03-30
• Primary completion: 2017-12-23
• Completion: 2017-12-23
• First posted: 2017-03-31
• Last updated: 2018-04-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study