A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy, Hepatic Insufficiency

Treatments: Drug: Palbociclib 75 mg Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02334800

A5481013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) of 18 to 40 kg/m2; and a total body weight >50 kg (110 lbs)
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion criteria

• Any condition possibly affecting drug absorption (eg, gastrectomy)
• A positive urine drug screen
• Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; male subjects with partners currently pregnant; male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for 90 days after the last dose of investigational product
• History of sensitivity to heparin or heparin-induced thrombocytopenia
• Blood donation of approximately 1 pint (500 mL) or more within 56 days prior to dosing
• Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol
• Use of tobacco or nicotine products in excess of 5 cigarettes per day (or equivalent)
• History of sensitivity to palbociclib

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

Healthy Volunteers

Experimental group

Description:

Cohort of Healthy Volunteers

Treatment:

Drug: Palbociclib 75 mg Capsule

Mild Hepatic Impairment

Experimental group

Description:

Cohort of mild hepatic impairment subjects meeting the criteria for Child-Pugh Class A

Treatment:

Drug: Palbociclib 75 mg Capsule

Moderate Hepatic Impairment

Experimental group

Description:

Cohort of moderate hepatic impairment subjects meeting the criteria for Child-Pugh Class B

Treatment:

Drug: Palbociclib 75 mg Capsule

Severe Hepatic Impairment

Experimental group

Description:

Cohort of severe hepatic impairment subjects meeting the criteria for Child-Pugh Class C

Treatment:

Drug: Palbociclib 75 mg Capsule