Hepatic Impairment Clinical Trial
Official title:
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.
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
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.
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