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Evaluate Severe Hepatic Impairment on Dacomitinib PK

Last updated on April 4, 2019

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Study Location
Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Research Pharmacy
Miami, Florida, 33136 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Severe Hepatic Impairment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Participants are eligible to be included in the study only if all of the following criteria
apply:

1. Male and/or female participants of non childbearing potential must be 18 to 75 years
of age, inclusive, at the time of signing the informed consent document (ICD).

2. Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.

Weight:

3. Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lb).

4. Capable of giving signed informed consent as described in Appendix 1, which includes
compliance with the requirements and restrictions listed in the ICD and in this
protocol.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Participants are excluded from the study if any of the following criteria apply:

1. Any condition possibly affecting drug absorption (eg, gastrectomy).

2. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or IP administration or may
interfere with the interpretation of study results and, in the judgment of the
investigator, would make the participant inappropriate for entry into this study.

3. History of or current positive results for human immunodeficiency virus (HIV).

4. Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half lives preceding the first dose of IP used in this
study (whichever is longer).

5. Hypersensitivity to dacomitinib or its excipients.

6. A positive urine drug test. Participants with severe hepatic impairment (Cohort 1)
will be eligible to participate if their urine drug test is positive with a drug for a
prescribed condition that is not expected to interfere with the PK of dacomitinib.

7. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.

8. History of sensitivity to heparin or heparin induced thrombocytopenia.

9. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of this protocol.

10. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Sponsor employees, including their family members, directly involved in the conduct of
the study.

NCT03865446
Pfizer
Not yet recruiting
Evaluate Severe Hepatic Impairment on Dacomitinib PK

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

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Severe Hepatic Impairment
NCT03865446
All Genders
18+
Years
Multiple Sites

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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