BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Single Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects Incorporating a Comparison of Fed/Fasted Pharmacokinetics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- No of subjects with Adverse events(AE) from each observations
研究概览
简要总结
The objective of this study is to determine the safety and tolerability and to determine the Pharmacokinetic and Pharmacodynamic (PK/PD) of ascending single oral dose of BR-A-657 in healthy male subjects.
详细描述
BR-A-657 20, 50, 120, 240, 360, 480mg or placebo were administered once to healthy male subjects.
Pharmacokinetic and Pharmacodynamic(PK/PD) parameters were monitored at pre-specified times from each subjects.
PK parameters: Area Under the Curve(AUC), Cmax, half-life, etc. PD parameters: Aldosterone, Plasma renin activity, Angiotensin I, Angiotensin II Adverse events are reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male of 18-55 years old
- •Body Mass Index(BMI) 19-29kg/m2
- •subjects in good health
- •subjects with written informed consent
排除标准
- •subjects with multiple drug allergy or allergy to Angiotensin Receptor Blocker(ARB)
- •subjects with medication that affect drug absorption or elimination within 30days.
- •subjects with orthostatic hypotension of >20mmHg decrease of Systolic Blood Pressure(SBP)
- •subjects with history of neurologic, liver, renal, gastrointestinal, cardiovascular, psychological or other major disorder
研究组 & 干预措施
Arm A
BR-A-657 20mg or placebo
干预措施: BR-A-657 (Drug)
Arm B
BR-A-657 60mg or placebo
干预措施: BR-A-657 (Drug)
Arm C
BR-A-657 120mg or placebo
干预措施: BR-A-657 (Drug)
Arm D
BR-A-657 240mg or placebo
干预措施: BR-A-657 (Drug)
Arm E
BR-A-657 480mg or placebo
干预措施: BR-A-657 (Drug)
结局指标
主要结局
No of subjects with Adverse events(AE) from each observations
时间窗: up to 5~7days post-dose
1. AE reporting: Pre dose, 3, 12, 24h, (48 h: Groups C, D, E) post dose 2. Vital signs: Pre dose\*, 0.5, 1\*, 2, 4\*, 6, 8\*, 12 and 24\* h post dose (\*:both supine and standing) 3. ECG: Pre dose, 2, 4, 8 and 24 h post dose 4. Clinical laboratory examination: Pre dose and 24 h post dose 5. Physical examination: predose, 5\~7days post dose 6. Body weight: predose, 5\~7days post dose
次要结局
- Area under the plasma concentration time curve (AUC)(0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h)
- Maximum observed plasma concentration (Cmax)(0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h)
- Time of the maximum observed plasma concentration (Tmax)(0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h)
- Apparent total plasma clearance (CL/F)(0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h)
- Apparent plasma terminal elimination half life (t½)(0.5,1,1.5,2,3,4,6,8,12,16,24,(48: Groups C, D, E)h)