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 being studied for pharmacokinetics, meaning how the drug is absorbed, distributed, metabolized, and eliminated in the body. It is not approved for any specific disease and is currently in clinical development to evaluate its safety and drug effects.
BAY2327949 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY.
BAY2327949 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety, tolerability, and pharmacokinetic profile.
BAY2327949 has one completed Phase 1 clinical trial registered under NCT04004195. The study, titled "Study to Investigate Safety, Absorption, Elimination, and Drug Effect of BAY2327949 in Participants With Different Renal Function Status," was conducted in Germany with 32 participants.
BAY2327949 is the only name provided for this investigational drug. No alternative names or brand names have been reported for this compound in the available clinical trial information.