Pharmacokinetics of LCQ908 in Patients With Renal Impairment
Completed · Phase 1
Conditions studied: Renal Impairment
In brief
This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of renal impairment to healthy subjects
Key facts
- Study ID
- NCT01558323
- Run by
- Novartis Pharmaceuticals
- People needed
- 58
- Starts
- 2012-05-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2020-12-19
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify 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 qualify 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.
- Other protocol-defined inclusion/exclusion criteria may apply.
Where it is running
- Novartis Investigative Site — Orlando, Florida, United States
- Novartis Investigative Site — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.