Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY 1841788 · 2 trials · 1 indication
Exposure of non-conjugated dabigatran in plasma following a single administration of dabigatran etexilate AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose AUC(0-tlast): AUC from time 0 to the last data point \> LLOQ
Maximum plasma concentration of non-conjugated dabigatran in plasma following a single administration of dabigatran etexilate Cmax: maximum observed drug concentration in measured matrix after single dose administration
Exposure of midazolam in plasma following a single administration of midazolam
Maximum plasma concentration of midazolam in plasma following a single administration of midazolam
National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE)
Cmax: maximum drug concentration in plasma after single dose administration
tmax: time to reach maximum drug concentration in plasma after single (first) dose
AUC(0-12):AUC from time 0 to 12 hours after administration
Cmax: maximum drug concentration in plasma after single dose administration
tmax: time to reach maximum drug concentration in plasma after single (first) dose
AUC(0-12):AUC from time 0 to 12 hours after administration
Cmax: maximum drug concentration in plasma after single dose administration
tmax: time to reach maximum drug concentration in plasma after single (first) dose
AUC(0-12):AUC from time 0 to 12 hours after administration
Cmax: maximum drug concentration in plasma after single dose administration
Day -5 {pre dose, 0.5,1,1.5,3,5 ,8,12,24,36,48},Day -2 {before morning dose, 0.5,1,1.5,3,5,8, 12, 24, 36 and 48 h} ,Day 7 {before morning dose, 0.5, 1, 1.5,3,5,8,12 h (before evening dose)}
AUC(0-12):AUC from time 0 to 12 hours after administration
| Arm | Type | Description |
|---|---|---|
| BAY1841788/Healthy subjects | EXPERIMENTAL | Period 1: intake of Midazolam and Dabigatran etexilate at day 1 followed by Period 2: intake of Darolutamide at days 1-11 (twice daily), intake of dabigatran etexilate at days 3 and 9, intake of Midazolam at day 9 |
| BAY 1841788(ODM-201) | EXPERIMENTAL | Cohort 1: Safety, tolerability and PK of 300 mg dose given twice daily. Escalation to cohort 2 in case no safety relevant adverse event has been observed within 28 days after start of multiple dose (MD) Cohort 2: Safety, tolerability and PK of 600 mg dose given twice daily |
| Name | Type | Description |
|---|---|---|
| Dabigatran etexilate | DRUG | In Period 1, Day 1 a single dose of 75 mg will be administered after breakfast In Period 2, Day 3 a single dose of 75 mg will be administered prior to breakfast In Period 2, Day 9 a single dose of 75 mg will be administered after breakfast |
| Midazolam | DRUG | In Period 1, Day 1 a single dose of 1 mg will be administered after breakfast In Period 2, Day 9 a single dose of 1 mg will be administered after breakfast |
| BAY1841788 (darolutamide) | DRUG | In Period 2, Days 1-11 600 mg twice a day (as 2 x 300 mg tablets) will be administered after breakfast |
| BAY 1841788(ODM-201) | DRUG | Cohort 1: Single dose 300 mg BAY 1841788, followed by twice daily administration of the same dose for 12 weeks Cohort 2: Single dose 2x300 mg BAY 1841788, followed by twice daily administration of the same dose for 12 weeks. |
Inclusion Criteria: * Healthy subject - as determined by the investigator or medically qualified designee based on medical evaluations including medical history, physical examination, laboratory tests and cardiac monitoring. * Gender: Male. * Age: 45 to 65 years (inclusive) at the screening visit. ...
BAY 1841788 is an investigational small molecule being studied for prostate cancer, specifically metastatic hormone-sensitive prostate cancer and metastatic castration-resistant prostate cancer. It has also been evaluated in healthy volunteers for pharmacokinetic and drug interaction studies. The drug is still in clinical development and has not been approved by the FDA.
BAY 1841788 is an androgen receptor antagonist, meaning it blocks the action of androgens like testosterone, which can drive prostate cancer growth. By inhibiting the androgen receptor, the drug aims to slow or stop cancer progression. This mechanism is being tested in combination with standard therapies for metastatic prostate cancer.
BAY 1841788 is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker BAYRY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in prostate cancer patients.
BAY 1841788 is in Phase 1 clinical development. Two Phase 1 trials have been completed, including a dose escalation study in Japanese patients with metastatic castration-resistant prostate cancer and a drug interaction study in healthy volunteers. The drug remains investigational and is not yet approved.
BAY 1841788 has been studied in several completed trials. NCT02363855 was a Phase 1 dose escalation study in Japanese patients with metastatic castration-resistant prostate cancer. NCT02671097 and NCT03237416 were drug interaction studies in healthy volunteers. NCT02799602 was a Phase 3 trial combining darolutamide with standard therapy in metastatic hormone-sensitive prostate cancer.
Yes, BAY 1841788 is also known as darolutamide. Clinical trials listed under both names refer to the same drug. Darolutamide is the generic name used in later-stage studies, including the Phase 3 trial NCT02799602 for metastatic hormone-sensitive prostate cancer.