drugset / Trial / NCT03290443

A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.

NCT03290443

Phase 1 Completed 31 enrolled Celgene Corporation
NaSingle-groupOpen-labelTreatment

Summary

This is a multi-center, open-label study to assess the PK of single 100 mg oral dose of enasidenib (CC-90007) in subjects with 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 Pugh's Modification of Child's Classification of Severity of Liver Disease

Timeline

Start
2017-09-21
Primary completion
2018-10-26
Completion
2018-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Enasidenib Small molecule 100 mg Oral

Indications

No indication recorded.