A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy Participants
Open-label Randomized, Three-fold Cross-over, Single-center Interaction Study to Investigate the Influence of Multiple Doses of Acetylsalicylic Acid (ASA) (Aspirin) on the Pharmacodynamics of BAY 3389934 in Healthy Participants.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Bayer Clinical Trials Contact
- 电话号码:0018888422937
- 邮箱:clinical-trials-contact@bayer.com
学习地点
-
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Florida
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Miami、Florida、美国、33014
- 招聘中
- Clinical Pharmacology of Miami, LLC - Cardiology Department
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-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- 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, vital signs, laboratory tests, and cardiac monitoring.
- Body mass index within the range 18.0 to 29.9 kg/m^2 (inclusive) at screening visit.
- Male or female (Women of Non-Childbearing Potential [WONCBP]) Contraceptive use by participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Male participants: Participants are eligible to participate if they agree to the following during the study intervention period up to at least 1 day after end of infusion of study intervention to ensure sufficient elimination of BAY3389934 (5 times the elimination half-life of BAY3389934 is approximately 5 hours):
- Refrain from donating sperm
PLUS, either:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR
Must agree to use contraception /barrier as detailed below:
- Agree to use a male condom with female partner use of an additional highly effective contraceptive method with a failure rate of < 1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant
- Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person
- Female participants: A female participant is eligible to participate if she is a WONCBP.
- A WONCBP must have a negative highly sensitive pregnancy test (serum) within 24 hours before the first dose of study intervention, the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
- Medical disorder, condition 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.
- Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal.
- Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g. non-investigational medicinal products, challenge agents, or rescue medication.
- Known severe allergies, e.g. allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions.
- Aspirin hypersensitivity/ allergy.
- Febrile illness within 2 weeks before the start of the first study intervention.
- Known or suspected liver disorders and bile secretion/flow (cholestasis, also history of it).
- History of Morbus Meulengracht (Gilbert´s syndrome) or total bilirubin levels above ULN at screening.
- History of known or suspected malignant tumors.
- Tendency to develop keloids or major scars after injuries.
- Participants experienced surgery (6-months prior to first study intervention), or IM injection (2-week prior to first study intervention).
- Known disorders with increased bleeding risk (e.g., periodontosis, symptomatic hemorrhoids, acute gastritis, peptic ulcer, vascular malformations and also history of it).
- Known sensitivity to common causes of bleeding or bruises (e.g., nasal).
- Known congenital or acquired coagulation disorders (e.g. von Willebrand's disease, hemophilia, platelet dysfunction, etc.).
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Treatment sequence A-B-C
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1.
Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence.
Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
|
4 hours infusion of BAY3389934 in Dose A.
Single oral dose of 500 mg tablet or 100 mg tablet.
|
|
实验性的:Treatment sequence A-C-B
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1.
Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence.
Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
|
4 hours infusion of BAY3389934 in Dose A.
Single oral dose of 500 mg tablet or 100 mg tablet.
|
|
实验性的:Treatment sequence B-A-C
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1.
Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence.
Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
|
4 hours infusion of BAY3389934 in Dose A.
Single oral dose of 500 mg tablet or 100 mg tablet.
|
|
实验性的:Treatment sequence B-C-A
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1.
Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence.
Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
|
4 hours infusion of BAY3389934 in Dose A.
Single oral dose of 500 mg tablet or 100 mg tablet.
|
|
实验性的:Treatment sequence C-A-B
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1.
Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence.
Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
|
4 hours infusion of BAY3389934 in Dose A.
Single oral dose of 500 mg tablet or 100 mg tablet.
|
|
实验性的:Treatment sequence C-B-A
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1.
Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence.
Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
|
4 hours infusion of BAY3389934 in Dose A.
Single oral dose of 500 mg tablet or 100 mg tablet.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants with treatment-emergent adverse events (TEAEs)
大体时间:From first dose of study intervention until 14 days after last study intervention
|
An AE is any untoward medical occurrence in a clinical study participant, associated with the use of study intervention, whether or not considered related to the study intervention.
|
From first dose of study intervention until 14 days after last study intervention
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Ratios to baseline of Activated Partial Thromboplastin Time (aPTT) 4h and 5h after baseline
大体时间:4 hours and 5 hours after baseline
|
4 hours and 5 hours after baseline
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Ratios to baseline of Prothrombin Time (PT) 4 h and 5 h after baseline
大体时间:4 hours and 5 hours after baseline
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4 hours and 5 hours after baseline
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Maximum ratio to baseline of Activated Partial Thromboplastin Time (aPTT) from baseline to 24 h post dose
大体时间:Baseline and 24 hours post dose
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Baseline and 24 hours post dose
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Maximum ratio to baseline of Prothrombin Time (PT) from baseline to 24 h post dose
大体时间:Baseline and 24 hours post dose
|
Baseline and 24 hours post dose
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The 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 the scope, timepoint, and process of data access.
As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. 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.
Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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