Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1817080 · 9 trials · 8 indications
The raw 24-hour cough count measured by cough recording digital wearable monitoring device was standardized to an average hourly count. For the ratio between the geometric means of 24-hour cough count, the geometric mean of 24-hour cough count after 12 weeks of intervention was divided by the geometric mean of 24-hour cough count at baseline. btw = between geo = geometric
AUCu: Area under the Curve unbound
Cmax,u: maximum observed drug concentration in measured matrix after single dose administration (unbound)
Area under the concentration vs. time curve
The intensity of an AE is classified according to the following categories: * Mild: A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. * Moderate: A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. * Severe: A type of adverse event that requires intensive therapeutic intervention. The event interrupts usual activities of daily living, or significantly affects clinical status
The intensity of an AE is classified according to the following categories: * Mild: A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. * Moderate: A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. * Severe: A type of adverse event that requires intensive therapeutic intervention. The event interrupts usual activities of daily living, or significantly affects clinical status
| Arm | Type | Description |
|---|---|---|
| BAY1817080 dose A BID | EXPERIMENTAL | Each participant will be randomized to receive one of three oral doses of BAY 1817080 or placebo, administered twice daily over the course of 12 weeks. |
| BAY1817080 dose B BID | EXPERIMENTAL | Each participant will be randomized to receive one of three oral doses of BAY 1817080 or placebo, administered twice daily over the course of 12 weeks. |
| BAY1817080 dose C BID | EXPERIMENTAL | Each participant will be randomized to receive one of three oral doses of BAY 1817080 or placebo, administered twice daily over the course of 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Each participant will be randomized to receive one of three oral doses of BAY 1817080 or placebo, administered twice daily over the course of 12 weeks. |
| Treatment period: Placebo | PLACEBO_COMPARATOR | This arm consists of participants who complete the run-in period, and are still eligible, according to all in- and exclusion criteria for diagnosis of OAB with UUI based on bladder diary baseline data. Participants will be randomized to 12 weeks of double-blind treatment with matching placebo. |
| Treatment period: BAY1817080 | EXPERIMENTAL | This arm consists of participants who complete the run-in period, and are still eligible, according to all in- and exclusion criteria for diagnosis of OAB with UUI based on bladder diary baseline data. Participants will be randomized to 12 weeks of double-blind treatment with BAY1817080. |
| Arm A: Moderately impaired renal function | EXPERIMENTAL | Participants with moderately impaired renal function will receive multiple doses of BAY1817080. |
| Arm B: Normal renal function matched to Arm A | EXPERIMENTAL | Participants with normal renal function matched to Arm A will receive multiple doses of BAY1817080. |
| Arm C: End stage renal disease on dialysis | EXPERIMENTAL | Participants with ESRD requiring dialysis will receive single dose of BAY1817080. |
| Arm D: Normal renal function matched to Arm C | EXPERIMENTAL | Participants with normal renal function matched to Arm C will receive single dose of BAY1817080. |
| BAY1817080 Part A | EXPERIMENTAL | Healthy male participants will receive BAY1817080 given as an oral solution (study Part A) |
| [14C]BAY1817080 Part B | EXPERIMENTAL | Healthy male participants will receive BAY1817080 blended with \[14C\]BAY1817080 given as an oral solution (study Part B). |
| Arm A: Child-Pugh A | EXPERIMENTAL | Participants with mildly impaired hepatic function (Child-Pugh A) |
| Arm B: Child-Pugh B | EXPERIMENTAL | Participants with moderately impaired hepatic function (Child-Pugh B) |
| Arm C: Child-Pugh C | EXPERIMENTAL | Participants with severely impaired hepatic function (Child-Pugh C) |
| Arm D: Normal hepatic (Matched A and B) | EXPERIMENTAL | Participants with normal hepatic function matched to Arm A and B |
| Arm E: Normal hepatic (Matched to C) | EXPERIMENTAL | Participants with normal hepatic function matched to Arm C |
| Intervention ABCD | EXPERIMENTAL | Intervention A: Day 1 and 2: Supra-therapeutic dose of BAY1817080, three times daily (tid) Day 3: Supra-therapeutic dose of BAY1817080 and placebo to moxifloxacin, once Intervention B: Day 1 and 2: therapeutic dose of BAY1817080 and placebo to BAY1817080, tid Day 3: therapeutic dose of BAY1817080, placebo to BAY1817080 and placebo to moxifloxacin, once Intervention C: Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and moxifloxacin, once Intervention D: Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and placebo to moxifloxacin, once Subjects will receive intervention A, B, C and D sequentially. The washing-out period between each intervention is at least 14 days |
| Intervention BCDA | EXPERIMENTAL | Subjects will receive intervention B, C, D and A sequentially. The washing-out period between each intervention is at least 14 days |
| Intervention CDAB | EXPERIMENTAL | Subjects will receive intervention C, D, A and B sequentially. The washing-out period between each intervention is at least 14 days |
| Intervention DABC | EXPERIMENTAL | Subjects will receive intervention D, A, B and C sequentially. The washing-out period between each intervention is at least 14 days Note: the intervention sequences in this and above arms are examples, the actual order of intervention may differ from these examples |
| Dose escalation BAY1817080 | EXPERIMENTAL | Participants receive dose 1 to 3 of BAY1817080 as a single dose on Day 1. |
| Dose expansion BAY1817080 | EXPERIMENTAL | Participants receive the highest dose 3 of BAY1817080 twice daily (BID) from Day 1 until Day 13 and a single dose on Day 14. |
| Dose escalation Placebo | PLACEBO_COMPARATOR | Participants receive placebo tablets orally as a single dose on Day 1. |
| Dose expansion Placebo | PLACEBO_COMPARATOR | Participants receive placebo tablets as BID multiple doses from Day 1 until Day 13 and as a single dose on Day 14. |
| Dose 1 of BAY1817080 | EXPERIMENTAL | Study Part 1: Oral dose 1 of BAY1817080 twice daily with a loading dose administered three times on Day 1 |
| Dose 2 of BAY1817080 | EXPERIMENTAL | Study Part 1: Oral dose 2 of BAY1817080 twice daily with a loading dose administered three times on Day 1 |
| Dose 3 of BAY1817080 | EXPERIMENTAL | Study Part 1: Oral dose 3 of BAY1817080 twice daily with a loading dose administered three times on Day 1 |
| Dose 4 of BAY1817080 | EXPERIMENTAL | Study Part 1: Oral dose 4 of BAY1817080 twice daily with a loading dose administered three times on Day 1 |
| Placebo+BAY1817080 | EXPERIMENTAL | Study Part 2: Randomized crossover design in cough patients Placebo+4 different doses of BAY1817080 |
| BAY1817080+Placebo | EXPERIMENTAL | Study Part 2: Randomized crossover design in cough patients 4 different doses of BAY1817080+Placebo |
| BAY1817080 | EXPERIMENTAL | Study Part 1: Dose 1 to 7 of BAY1817080 (increasing dose levels; redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food \[American breakfast\]); Study part 2: Dose 1 to 4 of BAY1817080 together with an American breakfast (increasing dose levels; redosing of BAY1817080 at dose group 1, 2 and 4 together with food \[Continental breakfast\]) |
| Name | Type | Description |
|---|---|---|
| BAY1817080 | DRUG | Study drug BAY1817080 will be administered orally as tablet. |
| Placebo | DRUG | Matching Placebo for BAY1817080 will be administered orally as tablet. |
| [14C]BAY1817080 | DRUG | Oral single dose |
| Midazolam | DRUG | Midazolam will be administered intravenously with dose of 0.1 mg on Day 1. |
| Moxifloxacin | DRUG | Film-coated tablet |
| Matching Placebo | DRUG | Matching Placebo to BAY1817080 |
| Itraconazole | DRUG | Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1) |
Inclusion Criteria: * Adults ≥ 18 years of age at the time of signing the informed consent. * A cough that has lasted for at least 12 months (unresponsive to treatment options) with a diagnosis of refractory chronic cough and/or idiopathic (unexplained) chronic cough. * Persistent cough for at leas...
BAY1817080 is an investigational small molecule drug developed by Bayer AG. It has been studied in clinical trials for refractory and unexplained chronic cough, overactive bladder, and endometriosis related pain. It is not approved and remains in clinical development.
BAY1817080 has been evaluated in clinical trials for refractory and unexplained chronic cough, overactive bladder, and endometriosis related pain. It is an investigational therapy and has not been approved for any indication.
BAY1817080 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical trials evaluating the drug.
BAY1817080 is in Phase 1 development. Four clinical trials have been completed, including Phase 1 and Phase 2 studies, but the drug remains investigational and has not received FDA approval.
BAY1817080 has been studied in four completed trials: NCT04562155 in chronic cough, NCT04545580 in overactive bladder, NCT04487431 in healthy male participants, and NCT04471337 in participants with renal impairment. All trials are completed.