Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
Lead Sponsor:
Pfizer
Conditions:
Hepatic Impairment
Healthy Participants
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 sa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04016077
Start Date
July 19 2019
End Date
March 5 2020
Last Update
April 8 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Miami Division of Clinical Pharmacology
Miami, Florida, United States, 33136
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809