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The goal of this clinical study was to learn more about BAY1747846 compared to placebo when given as an injection into the vein in Japanese healthy male participants:
To answer the first question, the researchers compared the number and severity of medical problems the Japanese participants had after receiving BAY 1747846 at increasing doses and placebo respectively. Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.
To answer the second question, the researchers determined:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation of BAY1747846 | Experimental |
| |
| Matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1747846 | Drug | Single dose; IV injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-emergent adverse events | Up to 7 to 10 days after study drug administration (From the time of signing of the ICF until the last visit of follow-up.) | |
| Severity of treatment-emergent adverse events | Up to 7 to 10 days after study drug administration (From the time of signing of the ICF until the last visit of follow-up.) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed drug concentration in measured matrix after single dose administration (Cmax) | Pre-dose, on Day 1, Day 2, Day 3 and Day 4. | |
| Area under the concentration vs. time curve from zero to infinity after single dose (AUC) | Pre-dose, on Day 1, Day 2, Day 3 and Day 4. |
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Inclusion Criteria:
Exclusion Criteria:
Current smoker, or has smoked within 3 months prior to screening Clinical Study Protocol
Any severe disease within the last 4 weeks prior to administration of study drug
History of orthostatic hypotension, fainting spells and blackouts
Any malignant tumor and history thereof
Any clinically relevant finding at the physical examination
Any known disposition for allergic, anaphylactoid, hypersensitivity or idiosyncratic reactions, e.g. any history of clinical signs of hypersensitivity reaction to any contrast agent
Any clinically relevant deviation from reference ranges of the laboratory parameters at screening or alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin exceeding the Upper limit of normal range (ULN) by more than 10%, or creatinine above the ULN, or hemoglobin below 12 g/dL
Clinically relevant ECG findings, e.g.: Heart rate <45 or > 90 beats/min, PR >220 msec, QTcF >450 msec, QRS >120 msec, branch bundle block, any sign of coronary heart disease at screening
-. Abnormal vital signs, e.g.: Systolic blood pressure <90 or >140 mmHg, Diastolic blood pressure <45 or >90 mmHg at screening
Subjects who have participated in a clinical study of an investigational drug within 4 months or an approved drug within 3 months prior to administration of study drug
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOUSEIKAI Fukuoka Mirai Hospital | Fukuoka | 813-0017 | Japan |
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.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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The study is performed according to a single-blind design, i.e. the participant is blinded to the allocation of treatment.
| Matching placebo |
| Drug |
Single dose; IV injection. |
|
| Total body clearance of drug (CL) | Pre-dose, on Day 1, Day 2, Day 3 and Day 4. |
| Total body clearance of drug normalized by body weight (CL/bw) | Pre-dose, on Day 1, Day 2, Day 3 and Day 4. |