Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being developed by Bayer AG for the treatment of endometriosis. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its safety, tolerability, and how it is processed by the body.
BAY2328065 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded on the OTC market under the ticker symbol BAYRY. The company is conducting early-stage clinical trials to evaluate the drug's safety and pharmacokinetics in healthy participants.
BAY2328065 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not received FDA approval. It is being studied for the treatment of endometriosis, but further clinical trials are needed to establish its safety and efficacy.
BAY2328065 has been studied in two completed Phase 1 trials. The first, NCT03427788, evaluated single dose escalation, safety, tolerability, pharmacokinetics, relative bioavailability, and food effect in 72 healthy male participants in Germany. The second, NCT04851483, assessed different medicinal forms of the drug in 31 healthy male and female participants in Germany.
BAY2328065 is the only name provided for this investigational drug. No alternative names or brand names have been associated with it in the available clinical trial information. It is a small molecule being developed by Bayer AG for endometriosis and is currently in Phase 1 clinical trials.