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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Palbociclib 75mg; Drug: Palbociclib 125mg; Drug: Palbociclib 100mg; Drug: Palbociclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02059330

A5481032

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Healthy Subjects of Japanese Descent

Experimental group

Description:

Enrolled Japanese subjects will receive four palbociclib single doses of differing dose amounts in fixed sequence over four treatment periods.

Treatment:

Drug: Palbociclib

Drug: Palbociclib 100mg

Drug: Palbociclib 125mg

Drug: Palbociclib 125mg

Drug: Palbociclib 75mg

Healthy Non-Asian Subjects

Experimental group

Description:

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

Treatment:

Drug: Palbociclib 125mg

Drug: Palbociclib 125mg