Pharmacokinetics of LCQ908 in Patients With Renal Impairment

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.