A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
Condition: Hepatic Impairment; Healthy Participants
MeSH terms: Liver Diseases
Intervention: PF-06651600 30 mg
Intervention description: PF-06651600 in 10 mg oral tablets will be administered on days 1 to 10.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PF-06651600; Pharmacokinetics; Hepatic impairment

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 safety and tolerability of PF-06651600 will also be evaluated in this
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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:

          -  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