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

NCT02059330 | Completed Phase 1

• 1 other identifier: A5481032
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

Japanese PK-Bridging Study; dose-proportionality study; Palbociclib; PD-0332991; healthy volunteers

Outcome Measures

Primary Outcomes (4)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

  AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).

  0-120 hours

• Dose-normalised Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

  AUC (0 - 8)DN= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8) divided by dose. It is obtained from AUC (0 - t) plus AUC (t - 8) all divided by the administered dose.

  0-120 hours

• Maximum Observed Plasma Concentration (Cmax)

  0-120 hours

• Dose-Normalised Maximum Observed Plasma Concentration (Cmax)

  0-120 hours

Secondary Outcomes (6)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  0-120 hours

• Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  0-120 hours

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0-120 hours

• Plasma Decay Half-Life (t1/2)

  0-120 hours

• Apparent Oral Clearance (CL/F)

  0-120 hours

Study Arms (2)

Healthy Subjects of Japanese Descent

EXPERIMENTAL

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

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

Healthy Non-Asian Subjects

EXPERIMENTAL

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

Drug: Palbociclib 125mg

Interventions

Palbociclib 75mg 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.

Also known as: PD-0332991

Healthy Subjects of Japanese Descent

Palbociclib 125mg 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.

Also known as: PD-0332991

Healthy Subjects of Japanese Descent

Palbociclib 100mg 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.

Also known as: PD-0332991

Healthy Subjects of Japanese Descent

Palbociclib 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.

Also known as: PD-0332991

Healthy Subjects of Japanese Descent

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

palbociclib

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

US (1)