MedTrace Logo

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

NCT03097016 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-04-26

No results posted yet for this study

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.

Conditions

  • Renal Insufficiency

Interventions

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.

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Leon Carayannopoulos, MD · Celgene

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-30
Primary Completion
2017-12-23
Completion
2017-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03097016 on ClinicalTrials.gov