drugset / Trial / NCT03742882

A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects

NCT03742882

Phase 1 Completed 40 enrolled Celgene Corporation
NaSingle-groupOpen-labelTreatment

Summary

This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Child-Pugh Classification Criteria.

Timeline

Start
2018-12-06
Primary completion
2019-06-10
Completion
2019-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject CC-90001 Small molecule 200 mg Oral

Indications

No indication recorded.