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

Novartis

Status and phase: Completed; Phase 2

Conditions: Renal Impaired; Healthy Volunteer; Pharmacokinetics

Treatments: Drug: LCZ696A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01569828

CLCZ696A2205

2007-005482-36

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Renal Impaired Subjects

Experimental group

Description:

once daily administration of 400 mg LCZ696 for 5 days

Treatment:

Drug: LCZ696A

Drug: LCZ696A

Healthy Volunteers

Experimental group

Description:

once daily administration of 400 mg LCZ696 for 5 days

Treatment:

Drug: LCZ696A

Drug: LCZ696A