Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LCZ696A · 1 trial · 3 indications
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
| Arm | Type | Description |
|---|---|---|
| Renal Impaired Subjects | EXPERIMENTAL | once daily administration of 400 mg LCZ696 for 5 days |
| Healthy Volunteers | EXPERIMENTAL | once daily administration of 400 mg LCZ696 for 5 days |
| Name | Type | Description |
|---|---|---|
| LCZ696A | DRUG | - |
Inclusion Criteria: \- Exclusion Criteria: \-
LCZ696A is an investigational small molecule being studied for pharmacokinetics in nephrology. A completed Phase 2 trial evaluated its multiple dose pharmacokinetics and metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function. It is not approved and remains in clinical development.
LCZ696A is being developed by Novartis AG, which trades under the ticker NVS. The company sponsored a completed Phase 2 pharmacokinetic study of the drug in subjects with severe renal impairment and healthy volunteers.
LCZ696A is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any use.
LCZ696A has one completed clinical trial, NCT01569828, titled 'Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function.' This Phase 2 study enrolled 12 participants in Germany, Russia, and Serbia.
LCZ696A is the drug name used in the clinical trial record, while the trial title refers to LCZ696. The study evaluates the pharmacokinetics of LCZ696 and its metabolites, indicating LCZ696A and LCZ696 are used interchangeably for this investigational compound.