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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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ClinicalTrials.gov Identifier: NCT02059330
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Palbociclib 75mg Drug: Palbociclib 125mg Drug: Palbociclib 100mg Drug: Palbociclib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open Label Study To Investigate The Effect Of Dose And Ethnicity On Palbociclib (PD-0332991) Pharmacokinetics In Japanese Healthy Volunteers
Study Start Date : March 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Arm Intervention/treatment
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.
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

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




Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 0-120 hours ]
    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).

  2. Dose-normalised Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 0-120 hours ]
    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.

  3. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0-120 hours ]
  4. Dose-Normalised Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0-120 hours ]

Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0-120 hours ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0-120 hours ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast), all divided by the administered dose.

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0-120 hours ]
  4. Plasma Decay Half-Life (t1/2) [ Time Frame: 0-120 hours ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  5. Apparent Oral Clearance (CL/F) [ Time Frame: 0-120 hours ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  6. Apparent Volume of Distribution (Vz/F) [ Time Frame: 0-120 hours ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059330


Locations
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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02059330     History of Changes
Other Study ID Numbers: A5481032
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Keywords provided by Pfizer:
Japanese PK-Bridging Study
dose-proportionality study
Palbociclib
PD-0332991
healthy volunteers

Additional relevant MeSH terms:
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Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action