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Effect Of Modafinil And Pioglitazone On The Pharmacokinetics Of Palbociclib (PD-0332991)

Last updated on March 15, 2019

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Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT02222441
Pfizer
Completed
Effect Of Modafinil And Pioglitazone On The Pharmacokinetics Of Palbociclib (PD-0332991)

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