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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 March 14, 2019

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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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]

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