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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
Contact
1-800-718-1021
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 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

- Undergone porta-caval shunt surgery.

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

NCT01571388
Pfizer
Completed
A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment

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A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment
A Phase 1 Study To Evaluate The Single Dose Pharmacokinetics Of Dacomitinib (PF-00299804) In Subjects With Impaired Hepatic Function
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Healthy
  • Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction
Drug: dacomitinib
Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
August 2012
August 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 74 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01571388
A7471018
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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