Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment
Status:
Recruiting
Trial end date:
2021-09-28
Target enrollment:
Participant gender:
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.