Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
Condition: Hepatic Impairment; Healthy Volunteers
MeSH terms: Liver Diseases
Intervention: PF-06865571 100 mg
Intervention description: PF-06865571 in 100 mg oral tablet will be administered on Day 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Non-alcoholic Fatty Liver Disease; Non-alcoholic steatohepatitis

Summary:

      The current study is proposed to evaluate whether there is any clinically meaningful effect
      of hepatic impairment on the plasma PK of PF-06865571.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are 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 35.4 kg/m2, inclusive; and a total body weight >50 kg
             (110 lb), at the Screening visit; with a single repeat assessment of total body weight
             (and hence BMI), on a separate day permitted to assess eligibility, if needed.

          -  Capable of giving signed informed consent.

        Exclusion Criteria

          -  Any condition possibly affecting drug absorption (eg, prior bariatric
             surgery,gastrectomy, ileal resection).

          -  At Screening, participants with a positive result for human immunodeficiency virus
             (HIV) antibodies, as assessed by sponsor-identified central laboratory, with a single
             repeat permitted to assess eligibility, if needed.

          -  Other acute or chronic medical or psychiatric condition including recent (within the
             past year) or active suicidal ideation or behavior or laboratory abnormality that may
             increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the participant inappropriate for entry into
             this study.

          -  Previous administration with an investigational drug within 30 days (or as determined
             by the local requirement) or 5 half-lives preceding the first dose of investigational
             product used in this study (whichever is longer).

          -  Participants with known prior participation (ie, randomized and received at least 1
             dose of investigational product) in a study involving PF-06865571.

          -  A positive urine drug test, for illicit drugs on Day -1,

          -  At Screening or Day -1, a positive breath alcohol test.

          -  Male participants with partners who are currently pregnant.

          -  Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
             within 60 days prior to dosing and until the follow-up contact.

          -  Unwilling or unable to comply with the criteria in the Lifestyle Considerations.

          -  Investigator site staff members directly involved in the conduct of the study and
             their family members, site staff members otherwise supervised by the investigator, or
             Pfizer employees, including their family members, directly involved in the conduct of
             the study.