NCT03290443

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

A Phase 1, Open-Label Single-Dose Study to Assess the Pharmacokinetics of Enasidenib (AG 221, CC 90007) in Subjects With Moderate and Severe Hepatic Impairment.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

Subjects will be enrolled in Groups 1 through 4 as follows: * Group 1: Approximately 6 to 8 male and female subjects with moderate hepatic impairment (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group 1. * Group 2: Approximately 6 to 8 healthy male and female subjects with normal hepatic function will be enrolled in Group 2. Subjects in Group 2 will be matched to subjects in Group 1 with respect to sex, age (± 10 years), and weight (± 30 pounds). * Group 3: Approximately 6 to 8 male and female subjects with severe hepatic impairment (with a Child-Pugh score of ≥ 10 to ≤ 13) will be enrolled in Group 3. * Group 4: Approximately 6 to 8 healthy male and female subjects with normal hepatic function will be enrolled in Group 4. Subjects in Group 4 will be matched to subjects in Group 3 with respect to sex, age (± 10 years), and weight (± 30 pounds). This study employs a staged design as follows. * At least 4 subjects with moderate hepatic impairment must demonstrate satisfactory safety and tolerability for up to 8 days after dosing, before subjects with severe hepatic impairment may be dosed. * Two subjects with severe hepatic impairment must demonstrate satisfactory safety and tolerability for up to 8 days after dosing, before the remaining subjects with severe hepatic impairment may be dosed.

Conditions

• Hepatic Impairment

Interventions

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

Timeline

• Start date: 2017-09-21
• Primary completion: 2018-10-26
• Completion: 2018-10-26
• First posted: 2017-09-21
• Last updated: 2020-07-17

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study