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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569828
• Other study ID #: CLCZ696A2205
• Secondary ID: 2007-005482-36
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2012
• Last updated: August 27, 2015
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: August 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteer
• Pharmacokinetics
• Renal Impaired
• Renal Insufficiency

Intervention

Drug:
• LCZ696A

• LCZ696A
once daily administration of 400 mg LCZ696 for 5 days

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Neuss
Russian Federation	Novartis Investigative Site	Moscow
Serbia	Novartis Investigative Site	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Russian Federation,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)		1 and 5 days	No
Primary	(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)		1 and 5 days	No
Primary	AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)		1 and 5 days	No
Primary	T1/2 After Multiple Dose Administration (Day 5)	Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696	5 days	No
Primary	CL/F After Multiple Dose Administration (Day 5)	Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696	5 days	No
Primary	CLr After Multiple Dose Administration (Day 5)	Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696	5 days	No
Secondary	24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers		5 days	No