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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000129-29 | EudraCT Number |
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The primary objectives of this study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| BAY1902607+Matching Placebo | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1902607 | Drug | 3 different doses over the course of part 1 and 4 different doses over the course of part 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 1 | Approximately 5 weeks | |
| Number of subjects with Treatment-Emergent Adverse Events (TEAEs) by Severity in Part 2 | Approximately 12 weeks | |
| AUC of midazolam without BAY1902607 | Part 1 | At Day -1 |
| AUC of midazolam in combination with BAY1902607 | Part 1 | At Day 13 |
| Cmax of midazolam in combination with BAY1902607 | Part 1 | At Day 13 |
| Cmax of midazolam without BAY1902607 | Part 1 | At Day -1 |
| Number of Coughs Experienced by the Patient Within a 24-hour Period (24- hour cough count/hour) in Part 2 | Part 2: Coughs monitored by VitaloJAK cough recorder (Vitalograph) | 24 hours |
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Inclusion Criteria:
Part 1:
Part 2:
Confirmed post-menopausal woman (defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for 6 months before screening with documented serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL) or Woman without childbearing potential based on surgical treatment at least 6 weeks before screening, such as bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy (documented by medical report verification) or Woman of childbearing potential that agrees to use two reliable and acceptable methods of contraception simultaneously (one method used by the study patient and one method used by the partner) during the study and for at least 31 days (1 average menstrual cycle of 28 days plus approx. 5 half-lives of BAY 1902607) after the last dose. In addition during the study and for at least 31 days after the last dose women of child bearing potential are not allowed to donate oocytes.
Exclusion Criteria:
Part 1:
Part 2:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catharina Ziekenhuis | Eindhoven | North Brabant | 5623 EJ | Netherlands | ||
| Isala |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37041539 | Derived | Friedrich C, Francke K, Birring SS, van den Berg JWK, Marsden PA, McGarvey L, Turner AM, Wielders P, Gashaw I, Klein S, Morice AH. The P2X3 receptor antagonist filapixant in patients with refractory chronic cough: a randomized controlled trial. Respir Res. 2023 Apr 11;24(1):109. doi: 10.1186/s12931-023-02384-8. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Part 1: Sequential parallel-group Part 2: Two-arm crossover
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Part 2:
Randomized crossover design in cough patients 4 different doses of BAY1902607+matching placebo
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| Matching Placebo+BAY1902607 | Experimental | Part 2: Randomized crossover design in cough patients Matching placebo+4 different doses of BAY1902607 |
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| 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. |
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| Zwolle |
| 8025 AB |
| Netherlands |
| Queen's University | Belfast | Antrim | BT9 7BL | United Kingdom |
| Birmingham Heartlands Hospital | Birmingham | West Midlands | B9 5SS | United Kingdom |
| Castle Hill Hospital | Cottingham | HU16 5JQ | United Kingdom |
| King's College Hospital - NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| Medicines Evaluation Unit | Manchester | M23 9GP | United Kingdom |
| University Hospital of South Manchester | Manchester | M23 9LT | United Kingdom |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |