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

NCT ID: NCT01571388

Last Updated: 2013-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-08-31

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.

Conditions

Healthy; Otherwise Healthy Volunteers With Mild or Moderate Hepatic Dysfunction

Keywords

dacomitinib; PF-00299804; hepatic impairment; pharmacokinetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1

Healthy Subjects to receive dacomitinib

Group Type: EXPERIMENTAL

dacomitinib

Intervention Type: DRUG

Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.

Group 2

Subjects with mildly impaired hepatic function to receive dacomitinib

Group Type: EXPERIMENTAL

dacomitinib

Intervention Type: DRUG

Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.

Group 3

Subjects with moderately impaired hepatic function to receive dacomitinib

Group Type: EXPERIMENTAL

dacomitinib

Intervention Type: DRUG

Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.

Interventions

dacomitinib

Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.

Intervention Type: DRUG

dacomitinib

Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.

Intervention Type: DRUG

dacomitinib

Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Anaheim, California, United States

Pfizer Investigational Site

South Miami, Florida, United States

Countries

United States

References

Piscitelli J, Chen J, LaBadie RR, Salageanu J, Chung CH, Tan W. The Effect of Hepatic Impairment on the Pharmacokinetics of Dacomitinib. Clin Drug Investig. 2022 Mar;42(3):221-235. doi: 10.1007/s40261-022-01125-x. Epub 2022 Feb 23.

Reference Type: DERIVED

PMID: 35195881 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26048096 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471018&StudyName=A%20Study%20To%20Compare%20Pharmacokinetics%20Of%20Dacomitinib%20%28PF-00299804%29%20Between%20Healthy%20Subjects%20And%20Subjects%20With%20Mild%20And%20Moderate%20Hepatic%20

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Other Identifiers

A7471018

Identifier Type: -

Identifier Source: org_study_id