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 developed by Novartis AG (ticker NVS) in the nephrology therapeutic area. It has been studied in a Phase 2 pharmacokinetics trial in people with severe renal impairment compared with matched healthy subjects who had normal renal function. The specific disease indication for LCZ696A has not been publicly disclosed.
LCZ696A is being developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 2 pharmacokinetic study of LCZ696A conducted in Germany, Russia, and Serbia. No other developer or partner for LCZ696A is identified in the available program information.
LCZ696A is in Phase 2 development. Its only recorded clinical trial, NCT01569828, is a completed Phase 2 pharmacokinetic study. LCZ696A is investigational and has not been approved by the FDA for any indication based on the available program information.
LCZ696A has been evaluated in one 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. The Phase 2 study is completed, enrolled 12 participants, and was conducted in Germany, Russia, and Serbia.
NCT01569828 examined the multiple dose pharmacokinetics of LCZ696A and its metabolites in subjects with severe renal impairment compared with matched healthy subjects who had normal renal function. The completed Phase 2 trial enrolled 12 participants aged 18 years and older, including healthy volunteers, across Germany, Russia, and Serbia.