A Renal Impairment Study for PF-06651600
Renal Impairment
About this trial
This is an interventional basic science trial for Renal Impairment
Eligibility Criteria
Inclusion Criteria:
- 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 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
Sites / Locations
- Investigational Drug Services (IDS) University of Miami Hospitals and Clinics
- University of Miami Division of Clinical Pharmacology
- Prism Clinical Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
PF-06651600 Severe Renal Impairment
PF-06651600 Normal Renal Function
PF-06651600 Moderate Renal Impairment
PF-06651600 Mild Renal Impairment
This arm includes participants with severe renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
This arm includes participants with normal renal function who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
This arm is in Part 2 which will be conducted if decision criterion to proceed to Part 2 is met. This arm includes participants with moderate renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
This arm is in Part 2 which will be conducted if the decision criterion to proceed to Part 2 is met. The arm includes participants with mild renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10.