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
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02059330
- Run by
- Pfizer
- People needed
- 27
- Starts
- 2014-03-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2014-06-24
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Pfizer Investigational Site — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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