Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1902607 · 3 trials · 3 indications
Maximum concentration of BAY1902607 in blood
Maximum concentration of BAY1902607 in blood with concomitant administration of itraconazole
Area under the concentration versus time curve of BAY1902607 (time from 0 to 96 hours) after single dose
Area under the concentration versus time curve (time from 0 to 264 hours) after single dose of BAY1902607 and concomitant administration of itraconazole
Part 1
Part 1
Part 1
Part 1
Part 2: Coughs monitored by VitaloJAK cough recorder (Vitalograph)
AE is any untoward medical occurrence (i.e. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. AEs (except for those in the 60 mg dose group) were considered to be treatment-emergent if they had started or worsened within the interval from first study drug administration until the follow-up visit. For the 60 mg dose group, AEs were considered to be TEAEs if they had started or worsened within one of the following intervals: 1) from first administration of study medication in treatment period 1 to 15 days thereafter, 2) from second administration of study medication in treatment period 2 to 15 days thereafter, 3) from third administration of study medication in treatment period 3 to follow-up visit.
AEs were considered to be TEAEs if they had started or worsened within the interval from first study drug administration until the follow-up visit (except for the 60 mg dose group: from first study drug administration in treatment period 1 to 15 days thereafter; from second study drug administration in treatment period 2 to 15 days thereafter; from third study drug administration in treatment period 3 to follow-up visit). Classification of the intensity: Mild (usually transient and might have required only minimal treatment or therapeutic intervention, did not generally interfere with usual activities of daily living), Moderate (usually alleviated with additional specific therapeutic intervention, interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the research subject), Severe (required intensive therapeutic intervention, interrupted usual activities of daily living, or significantly affected clinical status).
| Arm | Type | Description |
|---|---|---|
| Healthy men | EXPERIMENTAL | Healthy male adults from Germany receiving BAY1902607 during study period 1 (length = 6 days) and BAY1902607 + Itraconazole during study period 2 (length = 15 days), separated by a washout phase. |
| Dose 1 of BAY1902607 | EXPERIMENTAL | Part 1: From Day 1 until Day 12 the dose 1 of BAY1902607 will be given twice daily in approximately 12 hour intervals. On Day 0 and Day 13, dose 1 of BAY1902607 will be given only once. |
| Dose 2 of BAY1902607 | EXPERIMENTAL | Part 1: From Day 1 until Day 12 the dose 2 of BAY1902607 will be given twice daily in approximately 12 hour intervals. On Day 0 and Day 13, dose 2 of BAY1902607 will be given only once. |
| Dose 3 of BAY1902607 | EXPERIMENTAL | Part 1: From Day 1 until Day 12 the dose 3 of BAY1902607 will be given twice daily in approximately 12 hour intervals. On Day 0 and Day 13, dose 3 of BAY1902607 will be given only once. |
| Matching placebo | EXPERIMENTAL | Part 1: From Day 1 until Day 12 the matching placebo will be given twice daily in approximately 12 hour intervals. On Day 0 and Day 13, matching placebo will be given only once. |
| BAY1902607+Matching Placebo | EXPERIMENTAL | Part 2: Randomized crossover design in cough patients 4 different doses of BAY1902607+matching placebo |
| Matching Placebo+BAY1902607 | EXPERIMENTAL | Part 2: Randomized crossover design in cough patients Matching placebo+4 different doses of BAY1902607 |
| Dose escalation BAY1902607 | EXPERIMENTAL | Dose 1 to 9 of BAY1902607 |
| Dose escalation Placebo | PLACEBO_COMPARATOR | Dose 1 to 9 of matching placebo |
| Name | Type | Description |
|---|---|---|
| BAY1902607 | DRUG | BAY1902607 is administered once orally as tablets on Day 2 of study period 1 and on Day 4 of study period 2. |
| Itraconazole | DRUG | Itraconazole is administered at a dose of 200 mg once a day (oral solution of 10 mg mL-1) on Day 1 to Day 14 of study period 2. |
| Matching placebo | DRUG | Matching placebo for BAY1902607 |
| Midazolam | DRUG | Part 1: The subjects will initially (Day -1) receive a sub-therapeutic dose of 1 mg midazolam as solution in the morning. |
| Placebo | DRUG | Escalating doses of Placebo; single dose administration; different dosage forms (redosing of Placebo at dose group 4 with different formulations; redosing of Placebo solid formulation at dose group 4 together with food) |
Inclusion Criteria: * Healthy, male adults * Body mass index ≥ 18 and ≤ 30.0 kg/m² * Body weight ≥ 50 kg Exclusion Criteria: * Known or suspected allergy or hypersensitivity to BAY1902607, itraconazole or any of their excipients * Contraindications to itraconazole (symptoms or history of ventricu...
BAY1902607 is an investigational small molecule being studied for use in chronic cough and for evaluating drug interactions. It has been tested in healthy volunteers and in patients with chronic cough as part of early clinical development.
BAY1902607 is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. The drug is currently in Phase 1 clinical development.
BAY1902607 is in Phase 1 clinical development. All three of its clinical trials have been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities.
BAY1902607 has been studied in three completed Phase 1 trials: NCT03212586, a single dose escalation study in healthy males; NCT03535168, a repeat dose study in healthy males and chronic cough patients; and NCT03789890, a drug interaction study with itraconazole.
Yes, BAY1902607 is the same drug as BAY 1902607. The name is written with or without a space between 'BAY' and the number, and both refer to the same investigational compound being developed by Bayer AG.