Status:
TERMINATED
A Renal Impairment Study for PF-06651600
Lead Sponsor:
Pfizer
Conditions:
Renal Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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...
Detailed Description
This is a Phase 1 non-randomized, open-label, parallel cohort, multi-site study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-06651600 after mult...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04037865
Start Date
August 19 2019
End Date
March 31 2020
Last Update
May 18 2021
Active Locations (3)
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1
Investigational Drug Services (IDS) University of Miami Hospitals and Clinics
Miami, Florida, United States, 33136
2
University of Miami Division of Clinical Pharmacology
Miami, Florida, United States, 33136
3
Prism Clinical Research, LLC
Saint Paul, Minnesota, United States, 55114