Conditions: Healthy, Hepatic Insufficiency
Keywords: Palbociclib, PD-0332991, Hepatic Impairment
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 28
Healthy volunteers: yes

Brief summary:
This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.

Detailed description:
This is a 4-cohort single period study. The four cohorts will consist of healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function. Each cohort will receive the same treatment consisting of a single oral 75mg dose of palbociclib administered with food. Serial PK samples will be drawn up to 120 hours post dose for the cohort consisting of healthy volunteers, and will continue until up to 192 hours post-dose for the cohorts of hepatic impairment subjects.

Arms:
arm 1: Cohort of Healthy Volunteers arm 2: Cohort of mild hepatic impairment subjects meeting the criteria for Child-Pugh Class A arm 3: Cohort of moderate hepatic impairment subjects meeting the criteria for Child-Pugh Class B arm 4: Cohort of severe hepatic impairment subjects meeting the criteria for Child-Pugh Class C

Interventions: intervention 1: Palbociclib 75 mg Capsule
Intervention descriptions: intervention 1: Single oral 75 mg dose of palbociclib followed by serial PK sampling up to 192 hours post-dose (up to 120 hours post-dose for the healthy volunteer cohort).

Protocol document: