Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1830839 · 2 trials · 2 indications
TEAE: treatment-emergent adverse event
QD:once daily administration TID: three times daily administration
BID:twice daily administration
If AUC(tlast-∞) \>20% of AUC then AUC(0-tlast) will replace AUC.
If AUC(tlast-∞) \>20% of AUC then AUC(0-tlast) will replace AUC.
AUC: area under the plasma concentration vs time curve from zero to infinity after single dose.
maximum observed drug concentration in plasma after single dose administration
| Arm | Type | Description |
|---|---|---|
| BAY1830839 arm | EXPERIMENTAL | Period 1: Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6, single dose. Period 2: Dose 1, Dose 2 and Dose 3, once daily over 10 days. Dose 4 and Dose 5, twice daily over 10 days. Dose 6, single dose on Day 1, three times daily (TID) for 9 days (Days 2-10). |
| Placebo arm | PLACEBO_COMPARATOR | Placebo tablets matching BAY1830839 |
| BAY1830839 | EXPERIMENTAL | Single Dose escalations |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| BAY1830839 | DRUG | Tablet, oral. |
| Placebo | DRUG | Tablet, oral. |
| Midazolam | DRUG | For all dose steps. Oral. Two single doses. One dose administered during pre-dose in Period 1 and the second dose administered on the last day of treatment with BAY1830839 or placebo in Period 2 |
| Methotrexate | DRUG | Only for Dose 3 step. Tablet, oral. Two single doses. One dose administered during pre-dose in Period 1 and the second dose administered on the last day of treatment with BAY1830839 or placebo in Period 2. |
Inclusion Criteria: * Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent. * Overtly healthy as determined by medical evaluation including (medical and surgical history, physical examination, laboratory tests, ECG, vital signs). * Confirmation of the par...
BAY1830839 is an investigational small molecule being developed by Bayer AG for the treatment of rheumatoid arthritis. It is currently in Phase 1 clinical development, with studies conducted in healthy volunteers and participants with rheumatoid arthritis to evaluate its safety, tolerability, and pharmacokinetics.
BAY1830839 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker BAYRY on the OTC market. The drug is an investigational small molecule in Phase 1 clinical development for rheumatoid arthritis.
BAY1830839 is in Phase 1 clinical development. Two Phase 1 trials have been completed, including a first-in-human single dose escalation study and a multiple oral dose study. The drug is investigational and has not been approved by regulatory authorities.
BAY1830839 has been studied in two completed Phase 1 clinical trials. NCT03540615 was a first-in-human single dose escalation study in healthy male participants and those with rheumatoid arthritis. NCT03965728 investigated safety, tolerability, pharmacokinetics, and drug-drug interactions of multiple oral doses in healthy male participants.
BAY1830839 is the sole name used for this investigational drug in clinical trial records. No alternative names have been associated with it in the available clinical trial information.
BAY1830839 is a small molecule being developed for rheumatoid arthritis. Its specific molecular target has not been disclosed in the available clinical trial information, so its mechanism of action is not described here.