Pharmacokinetics of LCQ908 in Patients With Renal Impairment

Novartis

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: LCQ908

Study type: Interventional

Funder types: Industry

Identifiers

NCT01558323

CLCQ908B2102

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

58 participants in 3 patient groups

LCQ908 (mild renal impairment plus healthy volunteers)

Experimental group

Description:

Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with mild renal impairment and will receive a single 40 mg dose of LCQ908.

Treatment:

Drug: LCQ908

LCQ908 (moderate renal impairment plus healthy volunteers)

Experimental group

Description:

Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with moderate renal impairment and will receive a single 40 mg dose of LCQ908.

Treatment:

Drug: LCQ908

LCQ908 (severe renal impairment plus healthy volunteers)

Experimental group

Description:

Healthy subjects will be matched pair-wise by, sex, race, age (±15 years) and weight (±20%) to subjects with severe renal impairment and will receive a single 40 mg dose of LCQ908.

Treatment:

Drug: LCQ908