A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment

NCT01571388

Last updated date
Study Location
Pfizer Investigational Site
Anaheim, California, 92801, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy, Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-74 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 years of age to <75 years of age. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests. Liver function tests, albumin and prothrombin time must be within normal range.

- Body Mass Index (BMI) of 18 to 35 kg/m2;

- An informed consent document signed and dated by the subject.

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

- Subjects in the normal hepatic function group (Group 1): No known or suspected hepatic impairment.

- For subjects in the hepatic impairment groups (Groups 2 and 3):

- Should satisfy the criteria for Class A or B of the modified Child-Pugh classification

- A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, CT scan, or MRI.

- Stable hepatic impairment, defined as no clinically significant change in disease status within the last 30 days, as documented by the subject's recent medical history

- Must be on a stable dose of medication and/or treatment regimen.

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, chronic diarrhea,
rapid transit).


- A positive urine drug screen.


- Females of childbearing potential, including those with tubal ligation. [To be
considered for enrollment, women of at least 45 years of age who are postmenopausal
(defined as being amenorrheic for at least 2 years) must have confirmatory FSH test
results at screening].


- In addition, subjects in the hepatic impairment groups (Groups 2 and 3) presenting
with any of the following will not be included in the trial:


- Hepatic carcinoma and hepatorenal syndrome or life expectancy <1 year.


- Undergone porta-caval shunt surgery.


- History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers
less than one month prior to study entry.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Healthy, Otherwise Healthy Volunteers With Mild or Moderate Hepatic DysfunctionA Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment
NCT01571388
  1. Anaheim, California
  2. South Miami, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment
Official Title  ICMJE A Phase 1 Study To Evaluate The Single Dose Pharmacokinetics Of Dacomitinib (PF-00299804) In Subjects With Impaired Hepatic Function
Brief Summary The study will determine if there are differences in how dacomitinib is absorbed and eliminated between healthy subjects and subjects with mild and moderately impaired hepatic function.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction
Intervention  ICMJE Drug: dacomitinib
Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.
Study Arms  ICMJE
  • Experimental: Group 1
    Healthy Subjects to receive dacomitinib
    Intervention: Drug: dacomitinib
  • Experimental: Group 2
    Subjects with mildly impaired hepatic function to receive dacomitinib
    Intervention: Drug: dacomitinib
  • Experimental: Group 3
    Subjects with moderately impaired hepatic function to receive dacomitinib
    Intervention: Drug: dacomitinib
Publications * Giri N, Masters JC, Plotka A, Liang Y, Boutros T, Pardo P, O'Connell J, Bello C. Investigation of the impact of hepatic impairment on the pharmacokinetics of dacomitinib. Invest New Drugs. 2015 Aug;33(4):931-41. doi: 10.1007/s10637-015-0256-0. Epub 2015 Jun 6.

*   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: September 25, 2012)
25
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2012)
24
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 18 years of age to <75 years of age. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests. Liver function tests, albumin and prothrombin time must be within normal range.
  • Body Mass Index (BMI) of 18 to 35 kg/m2;
  • An informed consent document signed and dated by the subject.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Subjects in the normal hepatic function group (Group 1): No known or suspected hepatic impairment.
  • For subjects in the hepatic impairment groups (Groups 2 and 3):

    • Should satisfy the criteria for Class A or B of the modified Child-Pugh classification
    • A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, CT scan, or MRI.
    • Stable hepatic impairment, defined as no clinically significant change in disease status within the last 30 days, as documented by the subject's recent medical history
    • Must be on a stable dose of medication and/or treatment regimen.

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (eg, gastrectomy, chronic diarrhea, rapid transit).
  • A positive urine drug screen.
  • Females of childbearing potential, including those with tubal ligation. [To be considered for enrollment, women of at least 45 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at screening].
  • In addition, subjects in the hepatic impairment groups (Groups 2 and 3) presenting with any of the following will not be included in the trial:

    • Hepatic carcinoma and hepatorenal syndrome or life expectancy <1 year.
    • Undergone porta-caval shunt surgery.
    • History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than one month prior to study entry.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 74 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 NCT01571388
Other Study ID Numbers  ICMJE A7471018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP