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Pharmacokinetics of LCQ908 in Patients With Renal Impairment

Primary Purpose

Renal Impairment

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LCQ908
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Impairment focused on measuring LCQ908, Renal Impairment, Pharmacokinetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

LCQ908 (mild renal impairment plus healthy volunteers)

LCQ908 (moderate renal impairment plus healthy volunteers)

LCQ908 (severe renal impairment plus healthy volunteers)

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) of LCQ908
Area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(0-inf)] of LCQ908
Maximum plasma concentration (Cmax) of LCQ908

Secondary Outcome Measures

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.
The apparent systemic clearance (CL/F) of LCQ908 following extra vascular administration
Time to maximum plasma concentration of LCQ908
The time required for the concentration of the drug to reach half of its original value
Apparent volume of distribution of LCQ908 during the terminal elimination phase following extra vascular administration
LCQ908 protein binding: unbound area under curve (AUCc) of LCQ908
LCQ908 protein binding: unbound observed maximum plasma (Cmax) of LCQ908
LCQ908 protein binding: unbound apparent systemic clearance from plasma (CL/Fu) following extra vascular administration

Full Information

First Posted
March 14, 2012
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01558323
Brief Title
Pharmacokinetics of LCQ908 in Patients With Renal Impairment
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
Keywords
LCQ908, Renal Impairment, Pharmacokinetics

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCQ908 (mild renal impairment plus healthy volunteers)
Arm Type
Experimental
Arm 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.
Arm Title
LCQ908 (moderate renal impairment plus healthy volunteers)
Arm Type
Experimental
Arm 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.
Arm Title
LCQ908 (severe renal impairment plus healthy volunteers)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
LCQ908
Intervention Description
Participants will receive a single oral dose of LCQ908
Primary Outcome Measure Information:
Title
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) of LCQ908
Time Frame
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
Title
Area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(0-inf)] of LCQ908
Time Frame
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
Title
Maximum plasma concentration (Cmax) of LCQ908
Time Frame
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 Outcome Measure Information:
Title
Number of participants with adverse events (AEs), serious adverse events (SAEs) and death
Description
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.
Time Frame
Day 29
Title
The apparent systemic clearance (CL/F) of LCQ908 following extra vascular administration
Time Frame
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
Title
Time to maximum plasma concentration of LCQ908
Time Frame
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
Title
The time required for the concentration of the drug to reach half of its original value
Time Frame
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
Title
Apparent volume of distribution of LCQ908 during the terminal elimination phase following extra vascular administration
Time Frame
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
Title
LCQ908 protein binding: unbound area under curve (AUCc) of LCQ908
Time Frame
10 and 24 hours
Title
LCQ908 protein binding: unbound observed maximum plasma (Cmax) of LCQ908
Time Frame
10 and 24 hours
Title
LCQ908 protein binding: unbound apparent systemic clearance from plasma (CL/Fu) following extra vascular administration
Time Frame
10 and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Novartis Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=11343
Description
Results for CLCQ908B2102 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

Pharmacokinetics of LCQ908 in Patients With Renal Impairment

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