Back to resultsMultiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
Primary Purpose
Pharmacokinetics, Renal Impaired, Healthy Volunteer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LCZ696A
LCZ696A
Sponsored by
About this trial
This is an interventional treatment trial for Pharmacokinetics focused on measuring LCZ696, pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Renal Impaired Subjects
Healthy Volunteers
Arm Description
once daily administration of 400 mg LCZ696 for 5 days
once daily administration of 400 mg LCZ696 for 5 days
Outcomes
Primary Outcome Measures
Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
T1/2 After Multiple Dose Administration (Day 5)
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
CL/F After Multiple Dose Administration (Day 5)
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
CLr After Multiple Dose Administration (Day 5)
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Secondary Outcome Measures
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
Full Information
NCT ID
NCT01569828
First Posted
March 30, 2012
Last Updated
August 27, 2015
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01569828
Brief Title
Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
Official Title
An Open Label, Parallel-group Study to Determine Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment Compared to Matched Healthy Subjects With Normal Renal Function
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharmacokinetics, Renal Impaired, Healthy Volunteer
Keywords
LCZ696, pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renal Impaired Subjects
Arm Type
Experimental
Arm Description
once daily administration of 400 mg LCZ696 for 5 days
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
once daily administration of 400 mg LCZ696 for 5 days
Intervention Type
Drug
Intervention Name(s)
LCZ696A
Intervention Type
Drug
Intervention Name(s)
LCZ696A
Intervention Description
once daily administration of 400 mg LCZ696 for 5 days
Primary Outcome Measure Information:
Title
Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
Time Frame
1 and 5 days
Title
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
Time Frame
1 and 5 days
Title
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
Time Frame
1 and 5 days
Title
T1/2 After Multiple Dose Administration (Day 5)
Description
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Time Frame
5 days
Title
CL/F After Multiple Dose Administration (Day 5)
Description
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Time Frame
5 days
Title
CLr After Multiple Dose Administration (Day 5)
Description
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Time Frame
5 days
Secondary Outcome Measure Information:
Title
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
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
Neuss
ZIP/Postal Code
41460
Country
Germany
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Belgrade
Country
Serbia
12. IPD Sharing Statement
Learn more about this trial
Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
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