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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Conditions

• Pharmacokinetics
• Renal Impaired
• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	LCZ696A
DRUG	LCZ696A	once daily administration of 400 mg LCZ696 for 5 days

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2012-04-03
• Last updated: 2015-09-29
• Results posted: 2015-09-29

Locations

3 sites across 3 countries: Germany, Russia, Serbia