NCT01297582已完成1 期
A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult 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
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests, ECGs, laboratory tests, physical examinations
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending single doses in healthy adult male and female subjects. The secondary objectives are to characterize the pharmacokinetic and pharmacodynamic profiles of ONO-6950 by measuring plasma concentrations of ONO-6950, pulmonary function, and potential cardiovascular effects. The tertiary objective of this study is to evaluate the effect of a meal upon the pharmacokinetic profile of ONO-6950.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smoking male or female subjects (18-55 inclusive)
- •Body mass index (BMI) of 19-35kg/m2 (inclusive)
- •For females, postmenopausal, non-lactating, and non-pregnant
排除标准
- •History or presence of clinical significant disease
研究组 & 干预措施
E
Experimental
干预措施: ONO-6950 (Drug)
P
Placebo Comparator
干预措施: ONO-6950 (Drug)
结局指标
主要结局
Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests, ECGs, laboratory tests, physical examinations
时间窗: up to 7 days
次要结局
- Characterization of PK and PD profiles of ONO-6950, including change from baseline in pulmonary function tests, and any potential cardiovascular effects(up to 7 days)
- Effect of food on ONO-6950 pharmacokinetics by comparison of PK profile between fasted and fed conditions(up to 15 days)
研究者
研究点 (1)
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