NCT02334800

Brief Summary

This 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 31, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 24, 2018

Completed
Last Updated

January 24, 2018

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

January 6, 2015

Results QC Date

June 8, 2017

Last Update Submit

June 8, 2017

Conditions

Healthy, Hepatic Insufficiency

Keywords

Palbociclib, PD-0332991, Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

  • Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)

    AUCinf is area under the plasma concentration time curve from time 0 extrapolated infinite time. It is calculated as AUClast + (Clast/kel), where AUClast is area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

    Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.

  • Maximum Plasma Concentration (Cmax)

    Cmax is maximum plasma concentration. It is observed directly from data.

    Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.

Secondary Outcomes (19)

  • Unbound AUCinf (AUCinf,u)

    Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.

  • Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)

    Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.

  • Unbound AUClast (AUClast,u)

    Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.

  • Apparent Clearance After Oral Dose(CL/F)

    Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.

  • Unbound CL/F (CLu/F)

    Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.

  • +14 more secondary outcomes

Study Arms (4)

Healthy Volunteers

EXPERIMENTAL

Cohort of Healthy Volunteers

Drug: Palbociclib 75 mg Capsule

Mild Hepatic Impairment

EXPERIMENTAL

Cohort of mild hepatic impairment subjects meeting the criteria for Child-Pugh Class A

Drug: Palbociclib 75 mg Capsule

Moderate Hepatic Impairment

EXPERIMENTAL

Cohort of moderate hepatic impairment subjects meeting the criteria for Child-Pugh Class B

Drug: Palbociclib 75 mg Capsule

Severe Hepatic Impairment

EXPERIMENTAL

Cohort of severe hepatic impairment subjects meeting the criteria for Child-Pugh Class C

Drug: Palbociclib 75 mg Capsule

Interventions

Palbociclib 75 mg CapsuleDRUG

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).

Also known as: Palbociclib, PD-0332991
Healthy VolunteersMild Hepatic ImpairmentModerate Hepatic ImpairmentSevere Hepatic Impairment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Weston Diagnostics (Ultrasound Facility)

Orlando, Florida, 32825, United States

Location

Related Links

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Results Point of Contact

Title
Pfizer ClinicalTrail.gov Call Center
Organization
Pfizer Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

January 6, 2015

First Posted

January 8, 2015

Study Start

March 31, 2015

Primary Completion

October 9, 2016

Study Completion

October 9, 2016

Last Updated

January 24, 2018

Results First Posted

January 24, 2018

Record last verified: 2017-05

Locations

US(2)