Phase 2
Completed N=12
Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
Pharmacokinetics · Renal Impaired · Healthy Volunteer
Source: ClinicalTrials.gov NCT01569828 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) — 0.5; 0.5; 0.5; 0.5 hour
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) |
0.5; 0.5; 0.5; 0.5; 3; 3 | — |
| PRIMARY (Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) |
5215; 2810; 4960; 2407; 15967; 14633 | — |
| PRIMARY AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5) |
5918; 4101; 5495; 4336; 254000; 146100 | — |
| PRIMARY T1/2 After Multiple Dose Administration (Day 5) |
2.030; 1.916; 38.55; 13.16; 26.40; 12.98 | — |
| PRIMARY CL/F After Multiple Dose Administration (Day 5) |
45100; 45900; NA; NA; 7370; 6792 | — |
| PRIMARY CLr After Multiple Dose Administration (Day 5) |
24.18; 111.8; 47.39; 436.9; 28.89; 299.4 | — |
| SECONDARY 24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers |
172.658; 177.833; 133.000; 187.000; 89.333; 156.833 | — |
Eligibility Criteria
Inclusion Criteria
-
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT01569828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.