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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
CC-90001
University of Miami Miller School of Medicine
Miami, Florida, United States
Orlando Clinical Research Center OCRC
Orlando, Florida, United States
Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, United States
The Texas Liver Institute
San Antonio, Texas, United States
Pharmacokinetic- AUC0-t
Estimation of AUC calculated from time zero to the last measured time point
Time frame: UP to approximately 7 Days
Pharmacokinetic- AUC0-∞
Estimation of AUC calculated from time zero to infinity
Time frame: UP to approximately 7 Days
Pharmacokinetic- Cmax
Estimation of observed maximum plasma concentration
Time frame: UP to approximately Day 1
Pharmacokinetic- Tmax
Estimation of time to Cmax
Time frame: UP to approximately Day 1
Pharmacokinetic- t1/2
Estimation of terminal elimination half-life
Time frame: Up to approximately 7 days
Pharmacokinetic- CL/F
Estimation of apparent clearance of drug from plasma after extravascular administration
Time frame: Up to approximately 7 days
Pharmacokinetic- Vz/F
Estimation of apparent volume of distribution during the terminal phase
Time frame: Up to approximately 7 days
Adverse Events (AEs)
Number of subjects with adverse event
Time frame: From enrollment until at least 28 days after completion of study treatment
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