A Renal Impairment Study for PF-06651600

• Status: Terminated
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1 non-randomized, open-label, parallel cohort study of PF-06651600 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with mild and moderate renal impairment (Part 2).

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

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Body mass index (BMI) of >/= 17.5 to50 kg (110 lb)

Additional inclusion criteria for subjects with renal impairment:

• Meet the following eGFR criteria during the screening period based upon 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

• Mild renal impairment (Part 2 only): eGFR between 60 and 89 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 drug regimen

Exclusion Criteria:

• Females of child-bearing potential must use an accepted, highly effective contraceptive method

• Renal transplant recipients

• Urinary incontinence without catheterization

• Subjects with clinically significant infections within the past 6 months prior to first dose of study drug, evidence of active or chronic infection requiring oral treatment within 4 weeks prior, history of disseminated herpes simplex or recurrent or disseminated herpes zoster

• Subjects with malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of skin or cervical carcinoma in situ

• HIV, Hepatitis B, or Hepatitis C infection

Additional exclusion criteria for subjects with renal impairment:

• Subjects requiring hemodialysis and peritoneal dialysis

• Screening BP >/=180 mmHg (systolic) or >/=110 mmHg (diastolic)

• Screening 12-lead ECG demonstrating QTcF >470 msec