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

NCT03290443 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-07-17

No results posted yet for this study

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

Conditions

  • Hepatic Impairment

Interventions

DRUG

Enasidenib

100 mg enasidenib (CC-90007)

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
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2018-10-26
Completion
2018-10-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03290443 on ClinicalTrials.gov