NCT01364441已完成1 期
A Double-Blind, Placebo-Controlled, Single-Dose Escalation and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 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
- 48
- 试验地点
- 1
- 主要终点
- Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of ONO-2952 across ascending single doses in healthy adult male and female subjects. The secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The tertiary objective of this study is to preliminarily evaluate the effect of a meal upon the PK profile of ONO-2952.
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 19-35 kg/m2 (inclusive)
- •For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception
排除标准
- •History or presence of clinically significant disease
研究组 & 干预措施
P
Placebo Comparator
干预措施: Placebo (Drug)
E
Experimental
干预措施: ONO-2952 (Drug)
结局指标
主要结局
Safety and tolerability of ONO-2952 using vital signs, ECGs, laboratory tests, physical examinations, and incidence/severity of adverse events
时间窗: up to 8 days
次要结局
- Characterization of PK of ONO-2952 through measurement of drug concentration in plasma and urine sample(up to 8 days)
- Effect of food on ONO-2952 pharmacokinetics by comparison of PK profile between fasted and fed conditions(up to 24 days)
研究者
研究点 (1)
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