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

Completed · Phase 1

Conditions studied: Hepatic Impairment, Healthy Participants

In brief

The purpose of this study is to characterize the effect of hepatic impairment on the pharmacokinetic(s) (PK) of PF-06651600 following administration of multiple once daily doses of PF-06651600. The safety and tolerability of PF-06651600 will also be evaluated in this study.

Key facts

Study ID

NCT04016077

Run by

Pfizer

People needed

18

Starts

2019-07-19

Expected to finish

2020-03-05

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Miami Division of Clinical Pharmacology — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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