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
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 5/5/2014 |
| Start Date: | March 2014 |
| End Date: | June 2014 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A Phase 1, Open Label Study To Investigate The Effect Of Dose And Ethnicity On Palbociclib (PD-0332991) Pharmacokinetics In Japanese Healthy Volunteers
This study will investigate the dose-proportionality of palbociclib pharmacokinetics in
healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will
receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days
between doses. Additionally, this study will investigate the effect of Japanese ethnicity of
palbociclib pharmacokinetics by comparing palbociclib pharmacokinetics at a single
dose-level between healthy subjects of Japanese descent and approximately fourteen healthy
non-Asian subjects.
healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will
receive four single doses of palbociclib (PD-0332991) with a minimum washout of 10 days
between doses. Additionally, this study will investigate the effect of Japanese ethnicity of
palbociclib pharmacokinetics by comparing palbociclib pharmacokinetics at a single
dose-level between healthy subjects of Japanese descent and approximately fourteen healthy
non-Asian subjects.
Inclusion Criteria:
- 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:
- 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
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