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

• Status: Completed
• Trial end date: 2016-10-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Palbociclib

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