Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Celgene
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.
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
