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Pecavaptan · 1 trial · 2 indications
Dose-normalized AUC (AUC/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Dose-normalized Cmax (Cmax/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Dose-normalized AUCu (AUCu/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
Dose-normalized Cmax,u (Cmax,u/D) of BAY1753011 was investigated as the dose for the severe renal impairment group was reduced to 15 mg.
| Arm | Type | Description |
|---|---|---|
| Healthy | EXPERIMENTAL | Age-, weight- and gender- matched control group of healthy volunteers received a single oral dose of 30 mg BAY1753011 tablet. |
| Mild renal impairment | EXPERIMENTAL | Subjects with mild renal impairment received a single oral dose of 30 mg BAY1753011 tablet. |
| Moderate renal impairment | EXPERIMENTAL | Subjects with moderate renal impairment received a single oral dose of 30 mg BAY1753011 tablet. |
| Severe renal impairment | EXPERIMENTAL | Subjects with severe renal impairment received a single oral dose of 15 mg BAY1753011 tablet. |
| Name | Type | Description |
|---|---|---|
| Pecavaptan (BAY1753011) | DRUG | 30 mg, immediate release tablet, single dose, oral |
Inclusion Criteria: * Male or female White participants (women without childbearing potential) * Aged from ≥18 years * body mass index above or equal 18.5 kg/m2 and below or equal 36 kg/m2 at the first screening visit * Participants with renal impairment: with an eGFR \<90 mL/min/1.73 m\^2 determin...
Pecavaptan is an investigational small molecule being developed for congestive heart failure. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with reduced kidney function, as well as in healthy volunteers.
Pecavaptan is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market. The drug is currently in Phase 1 clinical development for congestive heart failure.
Pecavaptan is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 study has been completed, which evaluated the drug's safety, tolerability, and pharmacokinetics in participants with reduced kidney function compared to those with normal kidney function.
Pecavaptan has one completed Phase 1 clinical trial registered as NCT05599997. This study, conducted in Germany, enrolled 32 participants and evaluated how the drug moves into, through, and out of the body, as well as its safety and effects, in participants with reduced kidney function compared to matched participants with normal kidney function.
Yes, Pecavaptan is also known as BAY1753011. The Phase 1 clinical trial NCT05599997 refers to the study treatment as BAY1753011. This alternative name is used in the clinical trial registration and may appear in scientific literature and regulatory documents.