Effect Of Modafinil And Pioglitazone On The Pharmacokinetics Of Palbociclib (PD-0332991)
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 2/8/2015 |
Start Date: | October 2014 |
End Date: | April 2015 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
A Phase 1, Open-label, Fixed-sequence, 2-cohort, 2-period Study To Investigate The Effect Of Modafinil And Pioglitazone Given As Multiple Doses On Single Dose Pharmacokinetics Of Palbociclib (Pd-0332991) In Healthy Volunteers
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.
modafinil and the weak CYP3A inducer pioglitazone on the pharmacokinetics of palbociclib.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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