BR-A-657, A Phase 1, Double-blind, Placebo-controlled, Ascending Multiple Oral Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 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 multiple oral dose of BR-A-657 in healthy male subjects.
详细描述
BR-A-657 120, 360, or placebo were administered once daily for 7days to 16 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
- •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 ARB
- •subjects with medication that affect drug absorption or elimination within 30days.
- •subjects with orthostatic hypotension of >20mmHg decrease of sbp
- •subjects with history of neurologic, liver, renal, GI, CV, psychological or other major disorder
研究组 & 干预措施
Arm A
BR-A-657 120mg or placebo
干预措施: BR-A-657 (Drug)
Arm B
BR-A-657 360mg 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 final(7th) dose
1. AE reporting: Day 1: Predose, 3 \& 12h, Days 2\~7: Predose, Days 8,9: Once daily, 5\~7days post final dose 2. Vital signs: Day 1: Predose, 0.5,1,2,4,8,12,24h,Days 3\~6: Predose Day 7: Predose, 0.5,1,2,4,8,12,24,48h, 5\~7days post final dose 3. ECG: Days 1 \& 7: Predose, 2, 4, 8 \& 24h, Day 4: Predose, 5\~7days post final dose 4. Laboratory examination: Days 1 \& 4: Predose, Day 7: Predose \& 24h, 5\~7days post final dose 5. Physical examination: predose, 5\~7days post final dose 6. Body weight: predose, Days 4 \& 8
次要结局
- Area under the plasma concentration time curve (AUC)(predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7)
- Maximum observed plasma concentration (Cmax).(predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7)
- parent plasma terminal elimination half life (t½)(predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7)
- Apparent total plasma clearance (CL/F)(predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7)
- Accumulation ratio (RA)(predose,0.5,1,1.5,2,3,4,6,8,12,16,24,(48)h on day 1 and day 7)