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

August 27, 2015 updated by: Novartis Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 117292
        • Novartis Investigative Site
  • Serbia
      • Belgrade, Serbia
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal Impaired Subjects
once daily administration of 400 mg LCZ696 for 5 days
Drug: LCZ696A
Drug: LCZ696A
once daily administration of 400 mg LCZ696 for 5 days
Experimental: Healthy Volunteers
once daily administration of 400 mg LCZ696 for 5 days
Drug: LCZ696A
Drug: LCZ696A
once daily administration of 400 mg LCZ696 for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 and 5 days
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
Time Frame: 1 and 5 days
1 and 5 days
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
Time Frame: 1 and 5 days
1 and 5 days
T1/2 After Multiple Dose Administration (Day 5)
Time Frame: 5 days
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
5 days
CL/F After Multiple Dose Administration (Day 5)
Time Frame: 5 days
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
5 days
CLr After Multiple Dose Administration (Day 5)
Time Frame: 5 days
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 30, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 3, 2012

Study Record Updates

Last Update Posted (Estimate)

September 29, 2015

Last Update Submitted That Met QC Criteria

August 27, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLCZ696A2205
  • 2007-005482-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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