Effect Of Modafinil And Pioglitazone On The Pharmacokinetics Of Palbociclib (PD-0332991)
Completed · Phase 1
Conditions studied: Healthy
In brief
This study is designed to evaluate the potential effect of the moderate CYP3A inducer modafinil and the weak CYP3A inducer pioglitazone on the pharmacokinetics of palbociclib.
Key facts
- Study ID
- NCT02222441
- Run by
- Pfizer
- People needed
- 14
- Starts
- 2014-10-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2015-02-20
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 (BMI) 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 disease.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Subjects with a self-reported history of addiction, especially to stimulants.
- A positive urine drug screen or alcohol breath test.
- 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 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
- New Haven Clinical Research Unit — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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