Effect Of Itraconazole On The Pharmacokinetics Of Palbociclib

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT02131298

Run by

Pfizer

People needed

12

Starts

2014-05-01

Expected to finish

2014-06-01

Last updated by the study team

2014-06-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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