Pharmacokinetics of LCQ908 in Patients With Renal Impairment
NCT ID: NCT01558323
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
58 participants
INTERVENTIONAL
2012-05-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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PARALLEL
OTHER
NONE
Study Groups
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LCQ908 (mild renal impairment plus healthy volunteers)
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.
LCQ908
Participants will receive a single oral dose of LCQ908
LCQ908 (moderate renal impairment plus healthy volunteers)
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.
LCQ908
Participants will receive a single oral dose of LCQ908
LCQ908 (severe renal impairment plus healthy volunteers)
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.
LCQ908
Participants will receive a single oral dose of LCQ908
Interventions
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LCQ908
Participants will receive a single oral dose of LCQ908
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Countries
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Related Links
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Results for CLCQ908B2102 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CLCQ908B2102
Identifier Type: -
Identifier Source: org_study_id