A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib
Completed · Phase 1
Conditions studied: Healthy, Hepatic Insufficiency
In brief
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.
Key facts
- Study ID
- NCT02334800
- Run by
- Pfizer
- People needed
- 28
- Starts
- 2015-03-31
- Expected to finish
- 2016-10-09
- Last updated by the study team
- 2018-01-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Orlando Clinical Research Center — Orlando, Florida, United States
- Weston Diagnostics (Ultrasound Facility) — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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