NCT01215773已完成1 期
Pharmacokinetics, Safety and Tolerability of BI 671800 HEA Given 200 mg b.i.d. or 400 mg b.i.d. Over 7 Days. A Randomised, Double Blind, Placebo Controlled Within Dose Groups Phase I Study in Healthy Male and Female Volunteers.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Vital signs (pulse rate (PR))
研究概览
简要总结
The main objectives of the multiple dose study are to investigate the safety, tolerability pharmacokinetics of BI 671800 HEA in healthy male and female volunteers following multiple oral administration of BI 671800
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
- Double
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 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 671800 HEA medium dose
Experimental
Tablet, oral administration with 240 mL of water for each treatment
干预措施: BI 671800 (Drug)
BI 671800 HEA high dose
Experimental
2 Tablets, oral administration with 240 mL of water for each treatment
干预措施: BI 671800 (Drug)
Placebo
Placebo Comparator
Matching to HEA 200 mg tablets, oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Vital signs (pulse rate (PR))
时间窗: 12 weeks
Adverse events
时间窗: 12 weeks
Clinical laboratory test (clinical chemistry)
时间窗: 12 weeks
Clinical laboratory test (urinalysis)
时间窗: 12 weeks
Physical examination
时间窗: 12 weeks
Vital signs (blood pressure (BP))
时间窗: 12 weeks
12-lead ECG (electrocardiogram)
时间窗: 12 weeks
Clinical laboratory test (haematology)
时间窗: 12 weeks
Assessment of tolerability by investigator
时间窗: 12 weeks
次要结局
- accumulation ratios RA,Cmax(up to day 12 post treatment)
- Cmax,ss (maximum plasma concentration of BI 671800 or BI 600957 at steady state)(up to day 12 post treatment)
- Cavg,ss (average measured plasma concentration of BI 671800 or BI 600957 at steady state)(up to day 12 post treatment)
- AUCτ,ss (area under the plasma concentration-time curve of BI 671800 or BI 600957 at steady state for the complete dosing interval τ)(up to day 12 post treatment)
- λz,ss (terminal rate constant of BI 671800 or BI 600957 in plasma at steady state)(up to day 12 post treatment)
- t1/2,ss (terminal half-life of BI 671800 or BI 600957 in plasma at steady state)(up to day 12 post treatment)
- Cmax (maximum plasma concentration of BI 671800 or BI 600957)(up to day 12 post treatment)
- tmax (time from dosing until maximum concentration of BI 671800 or BI 600957 is measured)(up to day 12 post treatment)
- AUC0-infinity (area under the plasma concentration-time curve of BI 671800 or BI 600957 from time of dosing extrapolated to infinity)(up to day 12 post treatment)
- AUCτ,1 (area under the plasma concentration-time curve of BI 671800 or BI 600957 for the complete dosing interval τ)(up to day 12 post treatment)
- AUC0-tz (area under the plasma concentration-time curve of BI 671800 or BI 600957 from time of dosing to time tz of last quantifiable concentration)(up to day 12 post treatment)
- tmax,ss (time from dosing until maximum concentration of BI 671800 or BI 600957 at steady state is measured)(up to day 12 post treatment)
- MRTpo,ss (mean residence time of BI 671800 in the body at steady state after oral administration)(up to day 12 post treatment)
- CL/F,ss (apparent clearance of BI 671800 at steady state following oral administration)(up to day 12 post treatment)
- Vz/F,ss (apparent volume of distribution of BI 671800 during the terminal phase at steady state following oral administration)(up to day 12 post treatment)
- RAUCτ,ss,M/P (ratio of AUCτ,ss of the BI 600957 to AUCτ,ss of BI 671800)(up to day 12 post treatment)
- RCmax,ss,M/P (ratio of Cmax,ss of the BI 600957 to Cmax,ss of BI 671800)(up to day 12 post treatment)
- accumulation ratios RA,AUC(up to day 12 post treatment)
- peak-trough fluctuation (PTF) of BI 671800(up to day 12 post treatment)
- peak-trough fluctuation (PTF) of BI 600957(up to day 12 post treatment)
- linearity index (LI) of BI 671800 in plasma(up to day 12 post treatment)
研究者
研究点 (1)
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