Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000516-29 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, researchers want to find whether the study drug BAY1817080 has an effect on the electrocardiogram (ECG). 40 healthy male or female participants with the age of 18 to 65 years will be enrolled into this study. The ECG of the participants will be monitored closely by the researchers to detect any change after intake of the study medication.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention ABCD | Experimental | Intervention A: Day 1 and 2: Supra-therapeutic dose of BAY1817080, three times daily (tid) Day 3: Supra-therapeutic dose of BAY1817080 and placebo to moxifloxacin, once Intervention B: Day 1 and 2: therapeutic dose of BAY1817080 and placebo to BAY1817080, tid Day 3: therapeutic dose of BAY1817080, placebo to BAY1817080 and placebo to moxifloxacin, once Intervention C: Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and moxifloxacin, once Intervention D: Day 1 and 2: Placebo to BAY1817080, tid Day 3: Placebo to BAY1817080 and placebo to moxifloxacin, once Subjects will receive intervention A, B, C and D sequentially. The washing-out period between each intervention is at least 14 days |
|
| Intervention BCDA | Experimental | Subjects will receive intervention B, C, D and A sequentially. The washing-out period between each intervention is at least 14 days |
|
| Intervention CDAB | Experimental | Subjects will receive intervention C, D, A and B sequentially. The washing-out period between each intervention is at least 14 days |
|
| Intervention DABC | Experimental | Subjects will receive intervention D, A, B and C sequentially. The washing-out period between each intervention is at least 14 days Note: the intervention sequences in this and above arms are examples, the actual order of intervention may differ from these examples |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1817080 | Drug | Film-coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 therapeutic dose | Baseline and Day 3 | |
| Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after multiple oral doses of BAY1817080 supra-therapeutic dose | Baseline and Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Time-matched, placebo-corrected change from baseline of the individually corrected QT interval after a single oral dose of moxifloxacin | Baseline and Day 3 | |
| Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Mannheim GmbH | Mannheim | Baden-Wurttemberg | 68167 | Germany |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Moxifloxacin | Drug | Film-coated tablet |
|
| Placebo | Drug | Matched placebo as film-coated tablet |
|
| Baseline and Day 3 |
| Time-matched, placebo-corrected change from baseline of the QT interval corrected according to Fridericia (QTcF) and Bazett (QTcB) after a single oral dose of moxifloxacin | Baseline and Day 3 |
| AUC(0-24)md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose | Area under the concentration vs. time curve from zero to 24 hours after multiple doses | Predose and up to 24 hours after last dose of BAY1817080 at Day 3 |
| AUC after a single oral dose of moxifloxacin | Area under the concentration vs. time curve from zero to infinity after single dose | Predose and up to 24 hours after single dose of moxifloxacin at Day 3 |
| Cmax,md after multiple oral doses of BAY1817080 therapeutic or supra-therapeutic dose | Maximum observed drug concentration in measured matrix after multiple doses | Up to 24 hours after last dose of BAY1817080 at Day 3 |
| Cmax after a single oral dose of moxifloxacin | Maximum observed drug concentration in measured matrix after single dose | Up to 24 hours after single dose of moxifloxacin at Day 3 |
| Incidences of treatment-emergent adverse events (TEAEs) after BAY1817080 therapeutic or supra-therapeutic dose | From the start of BAY1817080 administration until 7 days after last dose, assessed up to 10 days |
| ID | Term |
|---|---|
| D003371 | Cough |
| D004715 | Endometriosis |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided