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Also known as BAY2395840 tablet
BAY2395840 · 3 trials · 6 indications
NRS is an one-item assessment of average neuropathic pain intensity which is presented as an 11-point Likert scale with 0 as "no pain" and 10 as "worst imaginable pain".
| Arm | Type | Description |
|---|---|---|
| Group 1 (BAY2395840 - placebo) | EXPERIMENTAL | Participants will be randomly assigned to treatment regimen of double-blind BAY2395840, and after an interim single blind period for washout will switch to double-blind placebo. |
| Group 2 (Placebo - BAY2395840) | EXPERIMENTAL | Participants will start with a treatment regimen of double-blind placebo, and after an interim single blind period for washout will switch to double-blind BAY2395840. |
| Dose step 1 | EXPERIMENTAL | Each participant will receive an single dose (SD) of dose 1 of BAY2395840 or matching placebo. |
| Dose step 2 | EXPERIMENTAL | Each participant will receive an single dose (SD) of dose 2 of BAY2395840 or matching placebo. |
| Dose step 3 | EXPERIMENTAL | Each participant will receive an single dose (SD) of dose 3 of BAY2395840 or matching placebo. |
| Dose step 4 | EXPERIMENTAL | Each participant will receive multiple doses (MDs) of dose 3 of BAY2395840 or matching placebo. |
| Group 1 | EXPERIMENTAL | Participants received BAY2395840 dose A as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with the same BAY2395840 dose A1 as oral solution under diet 1 conditions (Period 2) |
| Group 2 | EXPERIMENTAL | Participants received BAY2395840 dose C as tablets under diet 1 conditions. |
| Group 3 | EXPERIMENTAL | Participants received BAY2395840 dose E as tablets under diet 1 conditions. |
| Group 4 | EXPERIMENTAL | Participants received BAY2395840 dose H as tablets under diet 1 conditions |
| Group 5 | EXPERIMENTAL | Participants received BAY2395840 dose B as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions |
| Group 6 | EXPERIMENTAL | Participants received BAY2395840 dose C as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions |
| Group 7 | EXPERIMENTAL | Participants received BAY2395840 dose I as tablets under diet 1 conditions |
| Group 8 | EXPERIMENTAL | Participants received BAY2395840 dose G as tablets on Day 1, followed by 3 BAY395840 doses of dose F as tablets on Days 2 to 4 and subsequently 7 further BAY395840 doses of dose G as tablets on Days 5 to 11 under diet 1 conditions |
| Placebo matching Group 1 | PLACEBO_COMPARATOR | Participants received a dose of placebo as tablets under diet 1 conditions (Period 1). After the safety assessment for Period 1 and a washout period of at least 14 days participants were re-dosed with a single dose of placebo as oral solution under under diet 1 conditions (Period 2) |
| Placebo matching Group 2 to 4 and Group 7 | PLACEBO_COMPARATOR | Participants received a dose of Placebo as tablets under diet 1 conditions |
| Placebo matching Group 5 and 6 | PLACEBO_COMPARATOR | Participants received Placebo as tablets on Day 1 after diet 2, on Days 2 to 7 under diet 1 conditions |
| Placebo matching Group 8 | PLACEBO_COMPARATOR | Participants received a dose of Placebo as tablets on Day 1, followed by 3 doses of Placebo as tablets on Days 2 to 4 and subsequently 7 further doses of Placebo as tablets on Days 5 to 11 under diet 1 conditions. |
| Name | Type | Description |
|---|---|---|
| BAY2395840 | DRUG | Tablet, intake orally. |
| Placebo for BAY2395840 | DRUG | Tablet, intake orally. |
| BAY2395840 tablet | DRUG | tablets, oral administration |
| BAY2395840 oral solution | DRUG | solution, oral administration |
| Placebo oral solution | DRUG | Placebo matching BAY2395840, oral administration |
| Placebo tablet | DRUG | Placebo matching BAY2395840, oral administration |
Inclusion Criteria: * Adults ≥ 18 years of age at the time of signing the informed consent. * Have documented diagnosis of type 1 OR type 2 diabetes mellitus (DM). * Have painful distal symmetrical sensorimotor diabetic neuropathy for at least 6 months prior to the screening and confirmed at screen...
BAY2395840 is an investigational small molecule drug developed by Bayer AG for pain conditions. It has been studied in diabetic neuropathic pain, including neuropathic pain associated with diabetic peripheral neuropathy, and in endometriosis. It is a Phase 1 stage asset that has also completed a Phase 2 study in diabetic nerve pain.
BAY2395840 is being developed to treat pain, specifically diabetic neuropathic pain and neuropathic pain associated with diabetic peripheral neuropathy, as well as endometriosis. It is investigational and has not been approved for any indication. Clinical studies have enrolled healthy volunteers and participants with diabetic nerve pain.
BAY2395840 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the clinical studies of the drug, including Phase 1 trials in Japan and Germany and a Phase 2 trial in diabetic nerve pain conducted across several European countries.
BAY2395840 is in Phase 1 development, with a Phase 2 study also completed. It is investigational and has not been approved by the FDA or any regulator. The Phase 2 trial NCT05219812 evaluated safety and how well it works in participants with diabetic nerve pain.
BAY2395840 has been studied in three completed trials. NCT05563454 was a Phase 1 study in Japanese healthy male participants. NCT05517746 was a Phase 1 study in healthy male participants in Germany. NCT05219812 was a Phase 2 study in participants with diabetic nerve pain across Czechia, Germany, Hungary, Slovakia, Spain, and the United Kingdom.
Yes, BAY2395840 tablet refers to the oral tablet formulation of BAY2395840. A Phase 1 study, NCT05517746, compared the tablet and liquid formulations and assessed the effect of food on how the body absorbs, distributes, and excretes the drug in healthy male participants.