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

NCT ID: NCT02059330

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-06-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Palbociclib 75mg

Intervention Type: DRUG

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.

Palbociclib 125mg

Intervention Type: DRUG

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.

Palbociclib 100mg

Intervention Type: DRUG

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.

Palbociclib

Intervention Type: DRUG

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.

Healthy Non-Asian Subjects

Enrolled healthy non-Asian subjects will receive a single 125mg oral dose of palbociclib in a single treatment period.

Group Type: EXPERIMENTAL

Palbociclib 125mg

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

PD-0332991; PD-0332991; PD-0332991; PD-0332991; PD-0332991

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

New Haven, Connecticut, United States

Countries

United States

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5481032&StudyName=A%20Study%20To%20Investigate%20Palbociclib%20%28PD-0332991%29%20Pharmacokinetics%20In%20Healthy%20Subjects%20Of%20Japanese%20Descent%20Relative%20To%20Healthy%20Non-Asian%20S

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Other Identifiers

A5481032

Identifier Type: -

Identifier Source: org_study_id