Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY2328065 LSF · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Bridging part: intervention sequence ABC or BAC | EXPERIMENTAL | 10 healthy male participants will be randomly allocated to this arm. The study interventions will follow the sequence ABC or BAC: A: single dose of 50 mg BAY2328065 given as LSF in fasted state B: single dose of 50 mg BAY2328065 given as tablet in fasted state C: single dose of 50 mg BAY2328065 given as tablet in fed state (i.e. after a high caloric and high fat meal) |
| Multiple dose escalation part: dose 1 | EXPERIMENTAL | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day |
| Multiple dose escalation part: dose 2 | EXPERIMENTAL | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction |
| Multiple dose escalation part: dose 3 | EXPERIMENTAL | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction |
| Multiple dose escalation part: dose 4 | EXPERIMENTAL | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction |
| Multiple dose escalation part: dose 5 | EXPERIMENTAL | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by a treatment pause of 2 days followed by twice daily doses for 1 day followed by three times daily doses for 9 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction |
| Name | Type | Description |
|---|---|---|
| BAY2328065 LSF | DRUG | 20 mg/mL LSF (liquid service formulation), orally |
| BAY2328065 tablet | DRUG | 50 mg tablet, orally |
| Placebo LSF | DRUG | Matching Placebo LSF, orally |
| Placebo tablet | DRUG | Matching Placebo tablet, orally |
| Midazolam | DRUG | 1 mg per day, orally |
Inclusion Criteria: * Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG and vital signs * Confirmation of ...
BAY2328065 LSF is an investigational small molecule being developed for endometriosis. It is currently in Phase 1 clinical development, meaning it has not been approved by regulatory authorities and is still being studied for safety and tolerability in humans.
The specific molecular target of BAY2328065 LSF has not been disclosed in available clinical trial information. The drug is being studied for its effects in endometriosis, but its mechanism of action is not publicly detailed.
BAY2328065 LSF is being developed by Bayer AG, a multinational pharmaceutical company. Bayer is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug.
BAY2328065 LSF is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received approval from the FDA or other regulatory agencies for any use.
BAY2328065 LSF has been studied in one clinical trial, NCT04027192. This completed Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of multiple ascending doses in healthy male participants in Germany, with a total enrollment of 50 participants.
BAY2328065 LSF is a specific formulation or variant of the compound BAY2328065. The 'LSF' designation distinguishes this version in clinical development, but both names refer to the same investigational drug candidate being studied for endometriosis.