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A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers

Last updated on July 15, 2019

FOR MORE INFORMATION
Study Location
University of Miami Division of Clinical Pharmacology
Miami, Florida, 33136 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatic Impairment, Healthy Participants
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Willing and able to comply with all scheduled visits, treatment plan, laboratory
tests, lifestyle considerations and other study procedures

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

Additional Inclusion Criteria for Participants with Normal Hepatic Function:

- Healthy male or female participants

- No known or suspected hepatic disease

Additional Inclusion Criteria for Participants with Impaired Hepatic Function:

- Stable hepatic impairment, defined as no clinically significant change in disease
status within the last 30 days prior to the Screening visit

- No other ongoing clinically significant abnormalities based on medical history,
physical examination, vital signs, 12-lead ECG, and clinical laboratory tests except
for the abnormal findings that are related to the participant's hepatic impairment.

- Satisfy the criteria for Class A or Class B of the Child-Pugh classification (mild:
Child-Pugh Scores 5-6 points, and moderate: Child Pugh Scores 7-9 points), within 28
days of investigational product administration.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Has active acute or chronic infection requiring treatment or history of systemic
infection requiring hospitalization, incl. herpes zoster, herpes simplex, tuberculosis

- Infection with hepatitis B, hepatitis C or HIV

- Any condition affecting drug absorption, distribution, metabolism and excretion (eg,
status post porta-caval shunt surgery, prior bariatric surgery, gastrectomy, ileal
resection)

- Has malignancy, lymphoproliferative disorder, surgery or other condition not allowed
per protocol

Additional Exclusion Criteria for Participants with Normal Hepatic Function:

- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, gynecologic or
allergic disease

Additional Exclusion Criteria for Participants with Impaired Hepatic Function:

- Has encephalopathy, severe ascites and/or pleural effusion, Child-Pugh score >9 or
medical conditions (like hepatorenal syndrome, gastrointestinal hemorrhage, etc.) excluded
per protocol

NCT04016077
Pfizer
Not yet recruiting
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers

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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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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