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OpenTrials
Completed

NCT Number: NCT01569828

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

Completed

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Key information

Conditions

Pharmacokinetics Healthy Volunteer Renal Impaired

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Neuss, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

-

Treatment and study plan

LCZ696A

Drug

Primary outcomes

  1. 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

  2. (Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)

    Time frame: 1 and 5 days

  3. AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)

    Time frame: 1 and 5 days

  4. 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. 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

  6. 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

Secondary outcomes

  1. 24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 3, 2012
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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