Hepatic Impairment Clinical Trial
Official title:
A Phase 1, Open-label, Multicenter, Single-dose Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects
This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of
CC-90001 in subjects with mild, 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 Child-Pugh Classification Criteria.
Subjects will be enrolled in Groups 1 through 5 as follows:
- Group 1: Approximately 6 to 8 male or female subjects with mild hepatic impairment (with
a Child-Pugh score of ≥ 5 to ≤ 6) will be enrolled in Group 1.
- Group 2: Approximately 6 to 8 male or female subjects with moderate hepatic impairment
(with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group 2.
- Group 3: Approximately 6 to 8 healthy male or female subjects with normal hepatic
function will be enrolled in Group 3. Subjects in Group 3 will be matched to subjects in
Group 2 with respect to sex, age (± 10 years), and weight (± 10% body mass index [BMI]).
Group 3 will also serve as the control group for Group 1.
- Group 4: Approximately 6 to 8 male or female subjects with severe hepatic impairment
(with a Child-Pugh score of ≥ 10 to ≤ 13) will be enrolled in Group 4.
- Group 5: Approximately 6 to 8 healthy male or female subjects with normal hepatic
function will be enrolled in Group 5. Subjects in Group 5 will be matched to subjects in
Group 4 with respect to sex, age (± 10 years), and weight (± 10% BMI).
This study employs a staged design as follows:
- Subjects with mild or moderate hepatic impairment and matching healthy subjects with
normal hepatic function (Groups 1 through 3) will be enrolled concomitantly.
- At least 4 subjects with mild or moderate hepatic impairment must demonstrate
satisfactory safety and tolerability for up to 4 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 4 days after dosing before the remaining subjects with severe
hepatic impairment may be dosed.
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