drugset / Trial / NCT03290443
A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enasidenib | Small molecule | 100 mg | Oral |
Indications
No indication recorded.