NCT04573582

Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment

A Phase 1 Open-Label Single-Dose Study to Assess the Pharmacokinetics of Enasidenib (CC 90007) in Subjects With Mild, Moderate and Severe Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label study to assess the PK of single 100 mg oral doses of enasidenib (CC-90007) in subjects with mild, moderate, and severe hepatic impairment (HI), 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. Subjects will be enrolled in 4 Groups as follows: * Group A: Approximately 8 subjects with mild hepatic impairment (with a Child-Pugh score of \< 7) will be enrolled in Group A. * Group B: Approximately 8 subjects with moderate hepatic impairment (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group B. * Group C: Approximately 8 subjects with severe hepatic impairment (with a Child-Pugh score of ≥ 10 to ≤ 15) will be enrolled in Group C. * Group D: Approximately 8-24 healthy subjects with normal hepatic function will be enrolled in Group D. Subjects in Group D will be matched to subjects in Groups A-C with respect to sex, age (± 10 years), and weight (± 30 pounds). More than 1 subject with differing degrees of HI can be matched to a single control; however, all subjects with HI must be matched to at least 1 healthy match subject.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Enasidenib	100 mg enasidenib (CC-90007)

Timeline

• Start date: 2020-11-13
• Primary completion: 2023-03-08
• Completion: 2023-03-08
• First posted: 2020-10-05
• Last updated: 2024-07-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study