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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

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NCT02059330

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
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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.
Show details

- 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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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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: Palbociclib 75mg
    In Period 1, Japanese subjects will receive a single oral 75mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
    Other Name: PD-0332991
  • Drug: Palbociclib 125mg
    In Period 2, Japanese subjects will receive a single oral 125mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
    Other Name: PD-0332991
  • Drug: Palbociclib 100mg
    In Period 3, Japanese subjects will receive a single oral 100mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
    Other Name: PD-0332991
  • Drug: Palbociclib
    In Period 4, Japanese subjects will receive a single oral dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours. The amount of the dose will be determined based on an interim analysis of the PK data from Periods 1 and 2.
    Other Name: PD-0332991
  • Drug: Palbociclib 125mg
    In Period 1, healthy non-Asian subjects will receive a single oral 125mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
    Other Name: PD-0332991
  • Experimental: Healthy Subjects of Japanese Descent
    Enrolled Japanese subjects will receive four palbociclib single doses of differing dose amounts in fixed sequence over four treatment periods.
    Interventions:
    • Drug: Palbociclib 75mg
    • Drug: Palbociclib 125mg
    • Drug: Palbociclib 100mg
    • Drug: Palbociclib
  • Experimental: Healthy Non-Asian Subjects
    Enrolled healthy non-Asian subjects will receive a single 125mg oral dose of palbociclib in a single treatment period.
    Intervention: Drug: Palbociclib 125mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
June 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02059330
A5481032
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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