Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Palbociclib plus itraconazole

Drug: Palbociclib Alone

Study type

Interventional

Funder types

Industry

Identifiers

A5481016

Details and patient eligibility

About

This study is designed to evaluate the potential effect of itraconazole on the pharmacokinetics of palbociclib.

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
Body mass index of 17.5 to 30.5 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

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic diseases.
Any condition possibly affecting drug absorption.
A positive urine drug screen or alcohol breath test.
Pregnant female subjects; breast feeding 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 as outlined in this protocol for the duration of the study and for 90 days after the last dose of investigational product.