A Renal Impairment Study for PF-04965842
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: PF-04965842
Intervention description: PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD).
Intervention MeSH terms: Abrocitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Parallel Assignment
Intervention model description: Part 1 will be conducted. The 8 subjects from the renal impaired group will be recruited before recruiting the 8 subjects without renal impairment function in Part 1. After statistical evaluation of results from Part 1, Part 2 may be conducted.
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is a phase 1 non-randomized, open-label, single-dose, parallel-group study of PF
      04965842 in subjects with severe renal impairment and subjects without renal impairment (Part
      1) and in subjects with moderate renal impairment (Part 2).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Breath alcohol test at Screening and Day -1 must be negative.

          -  Body mass index (BMI) of ≥ 17.5 to ≤ 40.0 kg/m2; and a total body weight >50 kg (110
             lb).

        Additional inclusion criteria for subjects with renal impairment:

          -  Meet the following eGFR criteria during the screening period based on the MDRD
             equation:

               -  Severe renal impairment: eGFR <30 mL/min, but not requiring hemodialysis.

               -  Moderate renal impairment (Part 2 only): eGFR ≥30 mL/min and <60 mL/min.

          -  Any form of renal impairment except acute nephritic syndrome (subjects with history of
             previous nephritic syndrome but in remission can be included).

          -  Stable concomitant drug regimen.

        Exclusion Criteria:

          -  Renal transplant recipients.

          -  Urinary incontinence without catheterization.

          -  Subjects with clinically significant infections within the past 3 months (for example,
             those requiring hospitalization, or as judged by the Investigator), evidence of any
             infection (including influenza) within the past 7 days prior to baseline, history of
             disseminated herpes simplex infection or recurrent or disseminated herpes zoster.

          -  Subjects with a malignancy or with a history of malignancy, with the exception of
             adequately treated or excised non-metastatic basal cell or squamous cell cancer of the
             skin or cervical carcinoma in situ.

          -  History of or current positive results for human immunodeficiency virus, Hepatitis B,
             Hepatitis C.

        Additional exclusion criteria for subjects with renal impairment:

          -  Subjects requiring hemodialysis and peritoneal dialysis.

          -  Screening BP ≥ 180 mm Hg (systolic) or ≥ 110 mm Hg (diastolic).

          -  Screening supine 12-lead ECG demonstrating QTcF >470 msec or a QRS interval >120 msec.