Status:
COMPLETED
A Study to Learn About How Safe BAY3018250 is and What Happens to it in Healthy Japanese Men and Adult Participants Aged 18 to 55 Years
Lead Sponsor:
Bayer
Conditions:
Acute Venous and Arterial Thrombotic and Thromboembolic Events
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Researchers are looking for a better way to treat people who have acute venous and arterial thrombotic and thromboembolic events. These are severe medical problems due to blood clots forming in and bl...
Eligibility Criteria
Inclusion
- Inclusion:
- Part A:
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital signs, and electrocardiogram (ECG).
- Japanese who was born in Japan and whose parents and grandparents must have been Japanese and who has not lived outside of Japan for more than 10 years and has not significantly modified their diets since leaving Japan.
- Male
- Part B:
- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital signs, and ECG.
- Male or female (postmenopausal or hysterectomized only)
Exclusion
- Medical disorder, condition (e.g., after surgical procedure), or history of such that would impair the participant's ability to take part in or complete this study in the opinion of the investigator. This includes family history indicating hereditary predisposition of relevant diseases and history of non- persisting diseases with possible impact on study participation.
- Increased bleeding risk: known coagulation disorders (e.g., von Willebrand´s disease, hemophilia), periodontitis, symptomatic hemorrhoids, acute gastritis, peptic ulcer, or similar diseases with tendency to lead to bleedings, known sensitivity to common causes of bleeding (e.g., nasal, etc.), or history of hemorrhage and gastrointestinal ulceration within 6 months prior to the screening visit.
- Family history of hereditary or not explainable bleeding disorders.
- History of thrombosis or family history of hereditary or not explainable diseases with increased risk for thrombosis or thromboembolic events.
- Tendency of easy bruising.
- Platelets out of reference range.
- Activated partial thromboplastin time (aPTT) or prothrombin time (PT) out of reference range.
Key Trial Info
Start Date :
September 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2025
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06562985
Start Date
September 18 2024
End Date
January 6 2025
Last Update
February 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States, 90720