A Renal Impairment Study for PF-04965842

• Status: Completed
• Trial end date: 2019-11-05
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Abrocitinib

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.