A Phase 1 Study to Assess Pharmacokinetics and Pharmacodynamics Following Administration of BAY1093884 in Patients With Severe Hemophilia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- AUC (0-tlast) of BAY1093884 in plasma
研究概览
简要总结
The primary objective of this study is to assess the pharmacokinetics in patients with severe hemophilia.
The secondary objective is to assess the pharmacodynamics of BAY1093884 based on tissue factor pathway inhibitor activity
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males with severe congenital hemophilia A or B defined as <1% FVIII or <2% FIX concentration by measurement at the time of screening or from reliable prior documentation (e.g., measurement in other clinical Bayer trials, or diagnostic genetic testing)
- •Male with any inhibitor titer at screening or prior to screening at any time from medical records. Subjects may be receiving a bypassing agent (rFVIIa; NovoSeven and/or aPCC; FEIBA) for treatment.
- •Age: 18 to 65 years at screening
- •BMI: 18 to 29.9 kg/m2
排除标准
- •Subjects with known bleeding disorders (such as von Willebrand factor [vWF] deficiency, FXI deficiency, platelet disorders, or known acquired or inherited thrombophilia etc.) other than congenital Hemophilia A or B with or without inhibitors
- •History of angina pectoris or treatment for angina pectoris
- •History of coronary and/or peripheral atherosclerotic disease, congestive heart failure, disseminated intravascular coagulopathy, or stage 2 hypertension defined as systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg even if controlled
- •History of thrombophlebitis, venous/arterial thromboembolic diseases (particularly deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, cerebrovascular accident, ischemic heart disease, transient ischemic attack)
- •Known or suspected hypersensitivity of the immune system, history of anaphylactic reaction, known severe allergies, non-allergic drug reactions, or multiple drug allergies
- •Subjects with inhibitors treated with FEIBA, who are not willing to accept rFVIIa (NovoSeven) for the treatment of any bleeds occurring either between screening and dosing or after study drug administration, and until the end of the study.
研究组 & 干预措施
BAY1093884 in subjects with Hemophilia
Single dose of BAY1093884 over 30 minutes administered in subjects with severe congenital Hemophilia A or B, with inhibitors or without inhibitors
干预措施: BAY1093884 (Drug)
结局指标
主要结局
AUC (0-tlast) of BAY1093884 in plasma
时间窗: Up to 15 days after drug administration
Area under the concentration vs. time curve from time 0 to the last data point \> LLOQ
Cmax of BAY1093884 in plasma
时间窗: Up to 15 days after drug administration
Maximum observed drug concentration in measured matrix after single dose administration
Cmax/D of BAY1093884 in plasma
时间窗: Up to 15 days after drug administration
Cmax divided by dose
AUC(0-tlast)/D of BAY1093884 in plasma
时间窗: Up to 15 days after drug administration
AUC(0-tlast) divided by dose
次要结局
- Tissue factor plasma inhibitor activity: effect of BAY1093884 to inhibit the anticoagulatory activity of plasma TFPI as assessed by a chromogenic assay(Up to 15 days after drug administration)