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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000519-54 | EudraCT Number |
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Researchers are looking for a new way to treat people suffering either from a condition where the bladder is unable to hold urine normally (overactive bladder), or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis) or a condition where the cough lasts longer than 8 weeks in adults (chronic cough). BAY1817080 is a new drug that is in development as a potential treatment for these conditions.
In this trial, the researchers want to learn how a new liquid form of BAY1817080 is taken up by the body in a small number of healthy participants. The trial will include men who are aged 18 to 54.
The trial will have 2 parts: A and B. The participants in Part A will stay at the trial site for about 5 days. During this time, the participants will take 1 dose of a liquid form of BAY1817080 by mouth. The doctors will take blood and urine samples and check the participants' health. Part A will be done so the researchers can see how much BAY1817080 gets into the participants' blood. The participants in Part B will stay at the trial site for about 16 days followed by a maximum of 4 re-admission visits over 24 hours at intervals of 7 days. These participants will take 1 dose of a liquid form of BAY1817080 labeled with a radioactive substance (carbon 14), which means it is "radiolabeled". This allows the researchers to understand how BAY1817080 moves through and leaves the body. During Part B, the doctors will take blood, urine, stool, and vomit samples if applicable. They will also check the participants' health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1817080 | Drug | Oral single dose |
| |
| [14C]BAY1817080 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of BAY1817080 in plasma (Part A) | Area under the concentration vs. time curve | Pre-dose, post-dose on Day 1 (up to 16 hours), Days 2 to 4 (every 12 hours) |
| Maximum observed concentration of BAY1817080 in plasma (Cmax) (Part A) | Pre-dose, post-dose on Day 1 (up to 16 hours), Days 2 to 4 (every 12 hours) | |
| Radioactivity excreted in urine of BAY1817080 and its metabolites as a percentage of the dose (%AE,ur) (Part B) | Pre-dose, Day 1 (0-12 h and 12-24 h), Days 2 to 15, 22, 29, 36, 43 | |
| Radioactivity excreted in feces of BAY1817080 and its metabolites as a percentage of the dose (%AE,fec) (Part B) | Pre-dose, Days 1 to 15, 22, 29, 36, 43 | |
| Radioactivity excreted in vomit (if applicable) of BAY1817080 and its metabolites as a percentage of the dose (%AE,v) (Part B) | Up to 12 hours post-dose | |
| Whole blood to plasma ratio of total radioactivity (Part B) | Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15, 22, 29, 36, 43 | |
| AUC of [14C]BAY1817080 in Plasma (Part B) | Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15 | |
| Cmax of [14C]BAY1817080 in plasma (Part B) | Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15 | |
| AUC of total radioactivity (Part B) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-emergent adverse events (TEAEs) (Part A) | From first dose up to Day 15 | |
| Number of participants with maximum severity of TEAEs (Part A) | From first dose up to Day 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRAHealthSciences | Groningen | 9728 NZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38044419 | Derived | Reif S, Schultze-Mosgau MH, Engelen A, Piel I, Denner K, Roffel A, Tiessen R, Klein S, Francke K, Rottmann A. Mass Balance and Metabolic Pathways of Eliapixant, a P2X3 Receptor Antagonist, in Healthy Male Volunteers. Eur J Drug Metab Pharmacokinet. 2024 Jan;49(1):71-85. doi: 10.1007/s13318-023-00866-0. Epub 2023 Dec 3. |
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There are no current plans to share data. Interested researchers can use www.vivli.org 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 member section of the portal.
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| Drug |
Oral single dose |
|
| Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15, 22, 29, 36, 43 |
| Cmax of total radioactivity (Part B) | Pre-dose, post-dose on Day 1 (up to 12 hours), Days 2 to 10, 12, 15, 22, 29, 36, 43 |
| Number of participants with TEAEs (Part B) | From first dose up to Day 15 |
| Number of participants with maximum severity of TEAEs (Part B) | From first dose up to Day 15 |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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