Pharmacokinetics of LCQ908 in Patients With Renal Impairment

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of renal impairment to healthy subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.