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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001212-11 | EudraCT Number |
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To investigate the safety, tolerability, pharmacokinetics and effects of BAY1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single/multiple doses of 10 mg BAY1101042 or placebo | Experimental | Single oral dose of 10 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
|
| Single/ multiple doses of 20 mg BAY1101042 or placebo | Experimental | Single oral dose of 20 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
|
| Single/ multiple doses of 30 mg BAY1101042 or placebo | Experimental | Single oral dose of 30 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
|
| Single/ multiple doses of 40 mg BAY1101042 or placebo | Experimental | Single oral dose of 40 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
|
| Single/ multiple doses of 50 mg BAY1101042 or placebo | Experimental | Single oral dose of 50 mg BAY1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1101042 | Drug | Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Assessment of treatment emergent adverse events from first study drug intake until follow up | Approximately 19 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-24) of BAY1101042 | AUC(0-24): area under the concentration vs. time curve from zero to 24 hours after single dose | At day 1 |
| AUC(0-24)/D of BAY1101042 | AUC(0-24)/D: dose-normalized area under the concentration vs. time curve from zero to 24 hours after single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical-Research-Services Mönchengladbach GmbH | Mönchengladbach | North Rhine-Westphalia | 41061 | Germany | ||
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|
| Optional: Single/multiple doses of 5 mg BAY 1101042 or placebo | Experimental | Single oral dose of 5 mg BAY1101042 MR tablets or corresponding placebo followed by once daily dosing for 7 days |
|
| Placebo | Drug | Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d) |
|
| At day 1 |
| Cmax of BAY1101042 | Cmax: maximum observed drug concentration after single dose | At day 1 |
| Cmax/D of BAY1101042 | Cmax/D: dose-normalized maximum observed drug concentration after single dose | At day 1 |
| AUCτ,md of BAY1101042 | AUCτ,md: area under the concentration vs. time curve for the actual dosing interval after multiple dose | At day 9 |
| AUCτ,md/D of BAY1101042 | AUCτ,md/D: dose-normalized area under the concentration vs. time curve for the actual dosing interval after multiple dose | At day 9 |
| Cmax,md of BAY1101042 | Cmax,md: maximum observed drug concentration after multiple dose | At day 9 |
| Cmax,md/D of BAY1101042 | Cmax,md/D: dose-normalized maximum observed drug concentration after multiple dose | At day 9 |
| CRS Clinical Research Services Wuppertal GmbH |
| Wuppertal |
| North Rhine-Westphalia |
| 42113 |
| Germany |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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