Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY2327949 · 1 trial · 1 indication
Cmax: Maximum observed drug concentration in measured matrix after single dose administration
AUC:Area under the concentration vs. time curve from zero to infinity after single (first) dose. AUC(0-tlast) will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC
Cmax,u: Cmax based on the unbound plasma concentrations of the study drug
AUC(0-tlast)u will be used as primary variables if mean AUC(tlast-∞) \>20% of AUC
| Arm | Type | Description |
|---|---|---|
| Healthy participants | EXPERIMENTAL | - |
| Participants with mild renal impairment | EXPERIMENTAL | - |
| Participants with moderate renal impairment | EXPERIMENTAL | - |
| Participants with severe renal impairment | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BAY2327949 | DRUG | A single oral dose of 30 mg BAY2327949 given as one 30 mg IR tablet (dose might be reduced to 15 mg for group 4 according to safety assessment team decision) |
Inclusion Criteria: * Participant must be ≥18 years of age * The study enrolls healthy participants and participants at different stages of renal impairment (mild to severe renal impairment). * Race: White * BMI (body mass index): above or equal 18.5 and below or equal 35 kg/m\*2 at the first scree...
BAY2327949 is an investigational small molecule developed by Bayer AG. It has been studied in a Phase 1 clinical trial evaluating its safety, absorption, elimination, and drug effect in participants with different renal function status. The compound remains in early clinical development and its intended therapeutic indication has not been disclosed.
BAY2327949 is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the Phase 1 pharmacokinetic study of the compound conducted in Germany.
BAY2327949 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA for any indication.
BAY2327949 has been evaluated in one completed Phase 1 trial, NCT04004195, titled a study to investigate safety, absorption, elimination, and drug effect of BAY2327949 in participants with different renal function status. The trial enrolled 32 participants in Germany, including healthy volunteers, and used a controlled design.
The completed Phase 1 trial NCT04004195 evaluated the safety, absorption, elimination, and drug effect of BAY2327949 in participants with different renal function status. It enrolled 32 participants aged 18 years and older in Germany. The study was controlled but not randomized or double blinded.