Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Individuals with renal impairment only
* Estimated Creatinine Clearance (CLcr) by the Cockroft-Gault equation ≤80mL/min;
* Mild renal impairment defined as CLcr 50-80 mL/min
* Moderate renal impairment defined as CLcr 30-50 mL/min
* Severe renal impairment defined as CLcr \<30 mL/min
Healthy subjects only • Estimated CLcr by the Cockroft-Gault equation \>80mL/min
You may not be if
All Individuals
* A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
* Female subjects must be of non child bearing potential or use an effective method of contraception.
Individuals with renal impairment
* Renal transplant at any time.
* Subjects undergoing any method of dialysis (hemodialysis, peritoneal dialysis) within the last 3 months.
* History of clinically significant chronic or recurrent urinary tract infection active and requiring antibiotic treatment within the past 30 days.
* Any medication that is contraindicated in moderate or severe renally impaired population
Healthy subjects
* History or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and/or urea values, or abnormal urinary constituents (e.g., albuminuria)
* Evidence of urinary obstruction or difficulty in voiding at screening
* History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
