Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1841788 · 3 trials · 6 indications
Area under the concentration versus time curve from time zero to 72 hours of Darolutamide after single dose administration in plasma were measured.
Maximum observed concentration after single dose administration in plasma were measured.
Area under the concentration versus time curve from time zero to 72 hours of (S,R)-Darolutamide in plasma after single dose administration of Darolutamide were measured.
Maximum observed concentration of (S,R)-darolutamide in plasma after single dose administration of darolutamide were measured.
Area under the concentration versus time curve from time zero to 72 hours of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured.
Maximum observed concentration of (S,S)-darolutamide in plasma after single dose administration of darolutamide were measured.
Area under the concentration versus time curve from time zero to 72 hours (AUC\[0-72h\]) of keto-Darolutamide in plasma after single dose administration of darolutamide were measured.
Maximum observed concentration of keto-darolutamide in plasma after single dose administration of darolutamide were measured.
| Arm | Type | Description |
|---|---|---|
| ODM-201 | EXPERIMENTAL | All subjects will receive a single dose of BAY1841788 (ODM-201) (600 mg) in the first treatment period of the study, then all subjects will receive twice daily 200 mg itraconazole on 1 day and once daily 200 mg itraconazole for the following 6 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the second treatment period, then all subjects will receive once a day 600 mg rifampicin for 10 days and a single dose of BAY1841788 (ODM-201) (600 mg) in the third treatment period |
| Part 1 - Subjects with severe renal impairment | EXPERIMENTAL | Subjects with severe renal impairment received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets). |
| Part 1 - Subjects with moderate hepatic impairment | EXPERIMENTAL | Subjects with moderate hepatic impairment received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets). |
| Part 1 - Healthy subjects | EXPERIMENTAL | Healthy subjects received a single oral dose of darolutamide 600 mg (2 x 300 mg tablets). |
| BAY1841788 (ODM-201) + Rosuvastatin | EXPERIMENTAL | All subjects will receive a single dose BAY1841788 (ODM-201) (600 mg) followed by multiple doses BAY1841788 (ODM-201) (600 mg BID) as well as 2 times a single dose rosuvastatin (5 mg), once alone and once in combination with BAY1841788 (ODM-201). |
| Name | Type | Description |
|---|---|---|
| BAY1841788 (ODM-201) | DRUG | In Period 1, 600 mg single dose administered as 2x300 mg tablets on Study Day 1, In Period 2, 600 mg single dose administered as 2x300 mg tablets on Study Day 5, In Period 3, 600 mg single dose administered as 2x300 mg tablets at Study Day 8. |
| Itraconazole | DRUG | 200 mg twice daily (BID) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Day 1, 200 mg once daily (QD) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Days 2 to 7. |
| Rifampicin | DRUG | 600 mg QD administered as 1 x 600 mg tablet per dose in treatment period 3 on Study Days 1 to 10. |
| BAY1841788 | DRUG | 600 mg single dose, administered as 2 x 300 mg tablets on Day 00. |
| Rosuvastatin | DRUG | 5 mg tablet single dose on Day 01 in Period 1 and on Day 08 in Period 2. |
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.