NCT01203384已完成1 期
Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CERESPIR
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests.
排除标准
- •Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
- •Abnormal results of liver function tests, renal function tests or thyroid tests performed at screening.
- •Significant allergic conditions that require medical treatment
- •Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
- •Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.
研究组 & 干预措施
CHF5074 1x
Experimental
oral tablet, multidose
干预措施: CHF5074 1x (Drug)
CHF5074 2x
Experimental
oral tablet, multidose
干预措施: CHF5074 2x (Drug)
CHF5074 3x
Experimental
oral tablet, multidose
干预措施: CHF5074 3x (Drug)
Placebo
Placebo Comparator
placebo, oral tablet, multidose
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Events
时间窗: from Screening through Day 18
次要结局
- Dose linearity of CHF5074 plasma levels (Cmax)(Day -1 through Day 18)
- Dose linearity of CHF5074 plasma levels (AUC 0-t)(Day -1 through Day 18)
研究者
研究点 (1)
Loading locations...
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