Pharmacokinetics of LCZ696 in Subjects With Mild and Moderate Renal Impairment Compared to Healthy Subjects With Normal Renal Function

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety of LCZ696 in this population.

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Detailed Description

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Conditions

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Mild and Moderate Renal Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LCZ696 400 mg

LCZ696 400 mg once daily for 5 days

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

LCZ696 400 mg once daily

Interventions

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LCZ696

LCZ696 400 mg once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male, and female subjects of non-child bearing potential,
2. Subjects were to weigh at least 50 kg to participate in the study,
3. and body mass index \< 40 kg/m2
4. Subjects were able to communicate well with the investigator, to understand and comply with the requirements of the study;
5. Subjects were able to understand and sign the written informed consent;

For renal insufficient subjects:

1. stable renal disease without evidence of renal progressive

* mild renal function: calculated CrCl of 50-≤80 mL/min
* moderate renal function: calculated CrCl of 30-\<50 mL/min
2. Vital signs:

* oral body temperature between 35.0-37.8 °C
* systolic blood pressure, 95-180 mm Hg
* diastolic blood pressure, 60-110 mm Hg
* pulse rate, 54-95 bpm

For healthy subjects only

1. A serum creatinine with a calculated CrCl of \>80 mL/min
2. Vital signs:

* oral body temperature between 35.0-37.2 °C
* systolic blood pressure, 95-140 mm Hg
* diastolic blood pressure, 60-100 mm Hg
* pulse rate, 45-90 bpm

Exclusion Criteria

1. Current use of ACE inhibitors, valsartan, and drugs that were known as CYP2C9 substrates, potassium-sparing diuretics;
2. Smokers;
3. History of renal transplant at any time in the past and on immunosuppressant therapy;
4. Dialysis patients;
5. Medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome;

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes