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Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01569828
First received: March 30, 2012
Last updated: August 27, 2015
Last verified: August 2015
  Purpose
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

Condition Intervention Phase
Pharmacokinetics
Renal Impaired
Healthy Volunteer
Drug: LCZ696A
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • (Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) [ Time Frame: 1 and 5 days ] [ Designated as safety issue: No ]
  • AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) [ Time Frame: 1 and 5 days ] [ Designated as safety issue: No ]
  • T1/2 After Multiple Dose Administration (Day 5) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696

  • CL/F After Multiple Dose Administration (Day 5) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696

  • CLr After Multiple Dose Administration (Day 5) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal Impaired Subjects
once daily administration of 400 mg LCZ696 for 5 days
Drug: LCZ696A
Experimental: Healthy Volunteers
once daily administration of 400 mg LCZ696 for 5 days
Drug: LCZ696A
once daily administration of 400 mg LCZ696 for 5 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569828

Locations
Germany
Novartis Investigative Site
Neuss, Germany, 41460
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation, 117292
Serbia
Novartis Investigative Site
Belgrade, Serbia
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01569828     History of Changes
Other Study ID Numbers: CLCZ696A2205  2007-005482-36 
Study First Received: March 30, 2012
Results First Received: July 30, 2015
Last Updated: August 27, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
LCZ696
pharmacokinetics

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
LCZ 696
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016