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

Phase 2

Completed

• Conditions: Healthy Volunteer; Renal Impaired; Pharmacokinetics
• Interventions: Drug: LCZ696A

• Registration Number: NCT01569828
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-03
• Results First Submitted: 2015-07-30
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-27
• Last Update Submitted: 2015-08-27
• Results First Posted: 2015-09-29
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal Impaired Subjects	LCZ696A	once daily administration of 400 mg LCZ696 for 5 days
Healthy Volunteers	LCZ696A	once daily administration of 400 mg LCZ696 for 5 days

Primary Outcome Measures

Name	Time	Method
CL/F After Multiple Dose Administration (Day 5)	5 days	Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)	1 and 5 days
T1/2 After Multiple Dose Administration (Day 5)	5 days	Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)	1 and 5 days
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)	1 and 5 days
CLr After Multiple Dose Administration (Day 5)	5 days	Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696

Secondary Outcome Measures

Name	Time	Method
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers	5 days

Trial Locations

Locations (1)

Novartis Investigative Site; 🇷🇸 Belgrade, Serbia