Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers (a Partially Randomised, Partially Single-blind, Placebo-controlled Phase I Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number (%) of Subjects With Drug Related Adverse Events
研究概览
简要总结
In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 1015550 low dose A
Powder for oral solution
干预措施: BI 1015550 (Drug)
BI 1015550 low dose B
Powder for oral solution
干预措施: BI 1015550 (Drug)
BI 1015550 low dose C
Powder for oral solution
干预措施: BI 1015550 (Drug)
BI 1015550 low dose D
Powder for oral solution
干预措施: BI 1015550 (Drug)
BI 1015550 medium dose A
Powder for oral solution
干预措施: BI 1015550 (Drug)
BI 1015550 medium dose B
Powder for oral solution
干预措施: BI 1015550 (Drug)
BI 1015550 medium dose C
Powder for oral solution
干预措施: BI 1015550 (Drug)
BI 1015550 high dose A
Powder for oral solution
干预措施: BI 1015550 (Drug)
BI 1015550 high dose B
Powder for oral solution
干预措施: BI 101550 (Drug)
Placebo
Solution for oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Number (%) of Subjects With Drug Related Adverse Events
时间窗: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
Percentage of subjects with drug related adverse events.
Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests
时间窗: Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).
Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs
时间窗: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).
Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs
时间窗: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.
Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability
时间窗: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.
Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations
时间窗: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.
Percentage of subjects with clinically relevant abnormalities in physical examinations.
次要结局
- Cmax of BI 1015550(-0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing)
- AUC0-infinity of BI 1015550(-0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing)