Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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)
Healthy male or female participants
No known or suspected hepatic disease
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 be 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
\- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, gynecologic or allergic disease
\- Has encephalopathy, severe ascites and/or pleural effusion, Child-Pugh score \>9 or medical conditions (like hepatorenal syndrome, gastrointestinal hemorrhage, etc.) excluded per protocol
Clareo Health | A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
