Pharmacokinetics of LCQ908 in Patients With Renal Impairment

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.