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A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects

Last updated on February 17, 2019

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Study Location
Pfizer Investigational Site
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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- Subjects must be a healthy male or female of non-childbearing potential

- Subjects must have a BMI (Body Mass Index) between 17.5 and 30.5 kg/m2

- To be eligible for the Japanese cohort, subjects must have 4 biological grandparents
who are Japanese that were born in Japan

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any condition affecting drug absorption (eg gastrectomy, achlorhydria, etc)

- Use of prescription or non-prescription drugs

- A QTc-interval >450msec or a QRS interval >120msec

- Pregnant or breastfeeding females, females of childbearing potential, and males who
are unwilling or unable to use an effective method of contraception for the duration
of the study and for 90 days after the last dose of palbociclib in the study

NCT02059330
Pfizer
Completed
A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects

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Pfizer Clinical Trials Contact Center

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[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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