Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BAY2328065 tablet
BAY2328065 · 2 trials · 1 indication
AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose
Cmax: maximum observed drug concentration in measured matrix after single dose administration
The frequency of adverse events collected from dosing until follow up, i.e. 8 days after dosing
The severity of adverse events collected from dosing until follow up, i.e. 8 days after dosing Severity is assessed by the following criteria: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent or significant disability / incapacity 5. Is a congenital anomaly / birth defect 6. Is another serious or important medical event as judged by the investigator
| Arm | Type | Description |
|---|---|---|
| Group 1_BAY2328065 _male participants | EXPERIMENTAL | Approximately 6 participants will be randomly assigned to one of the 2 study intervention sequences (Group 1 or Group 2). |
| Group 2_BAY2328065 _male participants | EXPERIMENTAL | Approximately 6 participants will be randomly assigned to one of the 2 study intervention sequences (Group 1 or Group 2). |
| Group 3_BAY2328065 _male participants | EXPERIMENTAL | Approximately 8 participants will be assigned to the study intervention with one fixed sequence. |
| Group 4_BAY2328065 _female participants | EXPERIMENTAL | Approximately 9 participants will be randomly assigned to receive BAY2328065. |
| Group 4_Placebo _female participants | PLACEBO_COMPARATOR | Approximately 3 participants will be randomly assigned to receive placebo. |
| Verum | EXPERIMENTAL | Study group 1-11 of BAY2328065 (increasing dose levels for study group 2-11) |
| Placebo | PLACEBO_COMPARATOR | Study group 1-11 of Placebo |
| Name | Type | Description |
|---|---|---|
| BAY2328065 | DRUG | Solid Form, Oral administration. |
| Placebo | DRUG | Matching placebo of BAY2328065. |
Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent * Participants must be overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG, blood pressure and heart rate * C...
BAY2328065 is an investigational small molecule developed by Bayer AG for endometriosis, an endocrine condition. It is a tablet formulation and has been studied in Phase 1 clinical trials. BAY2328065 has not been approved for any indication and remains in early clinical development.
BAY2328065 is being developed as a potential treatment for endometriosis. Both of its completed Phase 1 trials listed endometriosis as the condition under study. The trials enrolled healthy volunteers rather than patients with endometriosis, so the program remains at an early stage of clinical development.
BAY2328065 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored both Phase 1 trials of the compound, which were conducted in Germany. No partner or licensing arrangement for BAY2328065 is disclosed.
BAY2328065 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and neither is currently active. The compound is investigational and has not been approved by the FDA or any other regulatory agency for the treatment of endometriosis.
Two completed Phase 1 trials have studied BAY2328065: NCT04851483, which compared different medicinal forms of the tablet in 31 healthy participants, and NCT03427788, a single dose escalation study of safety, tolerability, pharmacokinetics, relative bioavailability and food effect in 72 healthy male participants. Both were conducted in Germany.
Yes. BAY2328065 tablet is another name for BAY2328065, the oral small molecule developed by Bayer AG for endometriosis. The tablet form was specifically evaluated in the Phase 1 trial NCT04851483, which compared how different medicinal forms of BAY2328065 behave in the body.