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

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Healthy
Interventions
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.

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.

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.

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.

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.

Trial Locations (1)

06511

Pfizer Investigational Site, New Haven

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY