Status:
COMPLETED
A Study to Learn More About the Safety and the Level of BAY 1747846 in Body Given as Injection Into the Vein at Increasing Single Doses in Japanese Healthy Male Participants
Lead Sponsor:
Bayer
Conditions:
Contrast Enhancement in Magnetic Resonance Imaging
Healthy Volunteers
Eligibility:
MALE
20-40 years
Phase:
PHASE1
Brief Summary
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: * the safety of BAY1747846 when ...
Eligibility Criteria
Inclusion
- Signed informed consent prior to any study specific tests or procedures
- Ability and willingness to understand and follow study-related instructions
- Subject is healthy as determined by the investigator
- Japanese male
- Age 20 to 40 years (inclusive) at screening visit
- Body mass index (BMI): 18.0 to 28.0 kg/m\^2(inclusive)
- Body weight: at least 50 kg (inclusive)
- Subjects of reproductive potential must agree to use condoms whenever having sexual intercourse with a woman of child-bearing potential. This applies to the time period from signing of the ICF to at least 1 week after treatment.
Exclusion
- 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
Key Trial Info
Start Date :
April 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06125366
Start Date
April 17 2019
End Date
July 11 2019
Last Update
November 9 2023
Active Locations (1)
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1
SOUSEIKAI Fukuoka Mirai Hospital
Fukuoka, Japan, 813-0017