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

NCT ID: NCT02334800

Last Updated: 2018-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-10-09

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.

Conditions

Healthy, Hepatic Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy Volunteers

Cohort of Healthy Volunteers

Group Type: EXPERIMENTAL

Palbociclib 75 mg Capsule

Intervention Type: DRUG

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).

Mild Hepatic Impairment

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

Group Type: EXPERIMENTAL

Palbociclib 75 mg Capsule

Intervention Type: DRUG

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).

Moderate Hepatic Impairment

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

Group Type: EXPERIMENTAL

Palbociclib 75 mg Capsule

Intervention Type: DRUG

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).

Severe Hepatic Impairment

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

Group Type: EXPERIMENTAL

Palbociclib 75 mg Capsule

Intervention Type: DRUG

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).

Interventions

Palbociclib 75 mg Capsule

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).

Intervention Type: DRUG

Other Intervention Names

Palbociclib, PD-0332991

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Orlando Clinical Research Center

Orlando, Florida, United States

Weston Diagnostics (Ultrasound Facility)

Orlando, Florida, United States

Countries

United States

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5481013&StudyName=A%20Phase%201%2C%20Open-label%2C%20Single%20Dose%2C%20Parallel-cohort%20Study%20To%20Evaluate%20The%20Pharmacokinetics%20Of%20Palbociclib%20%28pd-0332991%29%20In%20Subjects%20With%20Impaired%20Hepatic%20Function

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Other Identifiers

A5481013

Identifier Type: -

Identifier Source: org_study_id