A Renal Impairment Study for PF-06651600
Stopped early · Phase 1
Conditions studied: Renal Impairment
In brief
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).
Key facts
- Study ID
- NCT04037865
- Run by
- Pfizer
- People needed
- 8
- Starts
- 2019-08-19
- Expected to finish
- 2020-03-31
- Last updated by the study team
- 2021-05-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Investigational Drug Services (IDS) University of Miami Hospitals and Clinics — Miami, Florida, United States
- University of Miami Division of Clinical Pharmacology — Miami, Florida, United States
- Prism Clinical Research, LLC — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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