Pharmacokinetics of LCQ908 in Patients With Renal Impairment
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/30/2013 |
| Start Date: | May 2012 |
| End Date: | January 2013 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | +1(862)778-8300 |
An Open-label, Parallel-group, Single Dose Study to Assess the Pharmacokinetics of LCQ908 in Patients With Mild, Moderate and Severe Renal Impairment Compared to Age, Gender and Weight-matched Healthy Volunteers.
This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of
renal impairment to healthy subjects
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials