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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01558323
Other study ID # CLCQ908B2102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 2012
Est. completion date March 2013

Study information

Verified date January 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LCQ908
Participants will receive a single oral dose of LCQ908

Locations

Country Name City State
United States Novartis Investigative Site Knoxville Tennessee
United States Novartis Investigative Site Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) of LCQ908 Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Primary Area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(0-inf)] of LCQ908 Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Primary Maximum plasma concentration (Cmax) of LCQ908 Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Secondary Number of participants with adverse events (AEs), serious adverse events (SAEs) and death AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital abnormalities or birth defects, or are other conditions which in the judgment of investigators represent significant hazards. Day 29
Secondary The apparent systemic clearance (CL/F) of LCQ908 following extra vascular administration Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Secondary Time to maximum plasma concentration of LCQ908 Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Secondary The time required for the concentration of the drug to reach half of its original value Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Secondary Apparent volume of distribution of LCQ908 during the terminal elimination phase following extra vascular administration Serial blood draws conducted on Day 1 (treatment day) followed by additional blood draws on Days 2-10,12, 14, 17, 21 and 29 post dosing
Secondary LCQ908 protein binding: unbound area under curve (AUCc) of LCQ908 10 and 24 hours
Secondary LCQ908 protein binding: unbound observed maximum plasma (Cmax) of LCQ908 10 and 24 hours
Secondary LCQ908 protein binding: unbound apparent systemic clearance from plasma (CL/Fu) following extra vascular administration 10 and 24 hours
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