Phase 2
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
Bottom Line
View on ClinicalTrials.gov: NCT01569828 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: 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 hour
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LCZ696A (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2009
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 | — |
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
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.