NCT01687920已完成1 期
Single Center, Randomized, Open-label, 5-fold Crossover Study in Healthy Male Subjects to Investigate the Pharmacokinetic Dose Proportionality of BAY94-8862 Given as 5 Different Single Oral IR Tablet Doses (1.25, 2.5, 5.0, 7.5 and 10 mg)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets
研究概览
简要总结
This study should estimate the dose proportionality of BAY94-8862 IR tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject
- •Age: 18 to 46 years (inclusive) at the first screening examination
- •Ethnicity: White
- •Body mass index (BMI): >= 18 and <= 29.9 kg / m²
排除标准
- •Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec
- •Systolic blood pressure below 100 or above 140 mmHg
- •Diastolic blood pressure below 50 or above 90 mmHg
- •Heart rate below 50 or above 95 beats/ min
- •Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
- •Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)
研究组 & 干预措施
BAY94-8862 (1.25mg)
Experimental
single dose BAY94-8862 IR tablet 1.25mg
干预措施: BAY94-8862 (1.25mg) (Drug)
BAY94-8862 (2.5mg)
Experimental
single dose BAY94-8862 IR tablet 2.5mg
干预措施: BAY94-8862 (2.5mg) (Drug)
BAY94-8862 (5mg)
Experimental
single dose BAY94-8862 IR tablet 5mg
干预措施: BAY94-8862 (5mg) (Drug)
BAY94-8862 (7.5mg)
Experimental
single dose BAY94-8862 IR tablet 7.5mg
干预措施: BAY94-8862 (7.5mg) (Drug)
BAY94-8862 (10mg)
Experimental
single dose BAY94-8862 IR tablet 10mg
干预措施: BAY94-8862 (10mg) (Drug)
结局指标
主要结局
Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets
时间窗: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h
次要结局
- Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862(Up to 48 h)
研究者
研究点 (1)
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