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A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib

Last updated on November 18, 2019

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Study Location
Orlando Clinical Research Center
Orlando, Florida, 32809 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatic Insufficiency Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Body Mass Index (BMI) of 18 to 40 kg/m2; and a total body weight >50 kg (110 lbs)

- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study

- Subjects who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, and other study procedures

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any condition possibly affecting drug absorption (eg, gastrectomy)

- A positive urine drug screen

- Pregnant female subjects; breastfeeding female subjects; female subjects of
childbearing potential; male subjects with partners currently pregnant; male subjects
of childbearing potential who are unwilling or unable to use a highly effective
method of contraception for the duration of the study and for 90 days after the last
dose of investigational product

- History of sensitivity to heparin or heparin-induced thrombocytopenia

- Blood donation of approximately 1 pint (500 mL) or more within 56 days prior to
dosing

- Unwilling or unable to comply with the Lifestyle Guidelines described in this
protocol

- Use of tobacco or nicotine products in excess of 5 cigarettes per day (or equivalent)

- History of sensitivity to palbociclib

NCT02334800
Pfizer
Completed
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib

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Descriptive Information
Brief Title  ICMJE A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib
Official Title  ICMJE A Phase 1, Open-label, Single Dose, Parallel-cohort Study To Evaluate The Pharmacokinetics Of Palbociclib (Pd-0332991) In Subjects With Impaired Hepatic Function
Brief SummaryThis is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of palbociclib administered to healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function.
Detailed DescriptionThis is a 4-cohort single period study. The four cohorts will consist of healthy volunteers, and subjects with mild, moderate, and severely impaired hepatic function. Each cohort will receive the same treatment consisting of a single oral 75mg dose of palbociclib administered with food. Serial PK samples will be drawn up to 120 hours post dose for the cohort consisting of healthy volunteers, and will continue until up to 192 hours post-dose for the cohorts of hepatic impairment subjects.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy, Hepatic Insufficiency
Intervention  ICMJE Drug: Palbociclib 75 mg Capsule
Single oral 75 mg dose of palbociclib followed by serial PK sampling up to 192 hours post-dose (up to 120 hours post-dose for the healthy volunteer cohort).
Other Name: Palbociclib, PD-0332991
Study Arms  ICMJE
  • Experimental: Healthy Volunteers
    Cohort of Healthy Volunteers
    Intervention: Drug: Palbociclib 75 mg Capsule
  • Experimental: Mild Hepatic Impairment
    Cohort of mild hepatic impairment subjects meeting the criteria for Child-Pugh Class A
    Intervention: Drug: Palbociclib 75 mg Capsule
  • Experimental: Moderate Hepatic Impairment
    Cohort of moderate hepatic impairment subjects meeting the criteria for Child-Pugh Class B
    Intervention: Drug: Palbociclib 75 mg Capsule
  • Experimental: Severe Hepatic Impairment
    Cohort of severe hepatic impairment subjects meeting the criteria for Child-Pugh Class C
    Intervention: Drug: Palbociclib 75 mg Capsule
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2015)
28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 9, 2016
Actual Primary Completion DateOctober 9, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body Mass Index (BMI) of 18 to 40 kg/m2; and a total body weight >50 kg (110 lbs)
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (eg, gastrectomy)
  • A positive urine drug screen
  • Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; male subjects with partners currently pregnant; male subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for 90 days after the last dose of investigational product
  • History of sensitivity to heparin or heparin-induced thrombocytopenia
  • Blood donation of approximately 1 pint (500 mL) or more within 56 days prior to dosing
  • Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol
  • Use of tobacco or nicotine products in excess of 5 cigarettes per day (or equivalent)
  • History of sensitivity to palbociclib
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02334800
Other Study ID Numbers  ICMJE A5481013
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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