Pharmacokinetics of LCQ908 in Patients With Renal Impairment

Renal Impairment Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558323
• Other study ID #: CLCQ908B2102
• Status: Completed
• Phase: Phase 1
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

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

External Links

•   Results for CLCQ908B2102 can be found on the Novartis Clinical Trial Results Website