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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000940-90 | EudraCT Number |
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Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as tablet or solution over 12 days to healthy male participants. Researcher want to study how the body absorbs, breaks down and excrete the new drug, also when given together with a test meal. In addition the study will investigate changes that take place in the body when BAY2328065 is given together with another drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bridging part: intervention sequence ABC or BAC | Experimental | 10 healthy male participants will be randomly allocated to this arm. The study interventions will follow the sequence ABC or BAC: A: single dose of 50 mg BAY2328065 given as LSF in fasted state B: single dose of 50 mg BAY2328065 given as tablet in fasted state C: single dose of 50 mg BAY2328065 given as tablet in fed state (i.e. after a high caloric and high fat meal) |
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| Multiple dose escalation part: dose 1 | Experimental | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day |
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| Multiple dose escalation part: dose 2 | Experimental | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction |
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| Multiple dose escalation part: dose 3 | Experimental | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY2328065 LSF | Drug | 20 mg/mL LSF (liquid service formulation), orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment-emergent adverse events (TEAEs) | From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant | |
| Severity of TEAEs | From first dosing up to 30 days after end of treatment with study intervention, summing up to approximately 39 to 45 days for a participant | |
| AUC(0-12)md (twice daily [BID]) | From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065 | |
| Cmax,md of BAY2328065 | From first dose of BAY2328065 until 72 hour after the last dose of BAY2328065 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Berlin GmbH | Berlin | 13353 | Germany |
Availability of this study's data will 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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The study will be performed in 2 study parts. Each participant will take part in one study part only.
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Open-label crossover in bridging part; double-blind, parallel group in multiple dose escalation part
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| Multiple dose escalation part: dose 4 | Experimental | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by twice daily doses for 10 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction |
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| Multiple dose escalation part: dose 5 | Experimental | 10 participants will be randomly allocated to active drug or placebo (8 active drug, 2 placebo). The study intervention will be administered with a single dose on the first dosing day followed by a treatment pause of 2 days followed by twice daily doses for 1 day followed by three times daily doses for 9 days followed by a single dose on the last dosing day Midazolam is given for investigation of drug-drug interaction |
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| BAY2328065 tablet | Drug | 50 mg tablet, orally |
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| Placebo LSF | Drug | Matching Placebo LSF, orally |
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| Placebo tablet | Drug | Matching Placebo tablet, orally |
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| Midazolam | Drug | 1 mg per day, orally |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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