An Exploratory, Randomised, Double-blind, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food-effect of TRK-750 in Healthy Adults and Patients With Peripheral Neuropathic Pain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Proportion of subjects with clinically significant changes in laboratory safety tests
研究概览
简要总结
This is an exploratory, randomised, double-blind, placebo-controlled, Phase I study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food-effect of single and multiple, ascending oral doses of TRK-750 in healthy adults and patients with peripheral neuropathic pain.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteers
- •Female subjects who are either:
- •Non-childbearing potential, or permanently sterile OR
- •Childbearing potential and agree to use at least one form of highly effective contraception
- •Male subjects, with a female sexual partner of childbearing potential or a pregnant or breastfeeding partner, must agree to use barrier contraception (male condom) for the treatment period and for at least three months after the end of the systemic exposure of the study drug.
- •Satisfactory medical assessment with no clinically significant or relevant abnormalities.
- •Ability to provide written, personally signed, and dated informed consent.
排除标准
- •Current or recurrent disease
- •Current or relevant history of physical or psychiatric illness
- •Positive test for Hepatitis B, Hepatitis C or human immunodeficiency virus antibody (HIV) at screening.
研究组 & 干预措施
TRK-750, single and multiple doses
干预措施: TRK-750 (Drug)
Placebo, single and multiple doses
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects with clinically significant changes in laboratory safety tests
时间窗: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:pulse rate(bpm)
时间窗: Up to 10-14days after last dose
Incidence of treatment-emergent adverse events as assessed by CTCAE v4.03
时间窗: Up to 10-14days after last dose
Proportion of subjects with morphological and/or rhythm abnormalities on electrocardiogram
时间窗: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:systolic blood pressure(mmHg)
时间窗: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in electrocardiogram time intervals
时间窗: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:diastolic blood pressure(mmHg)
时间窗: Up to 10-14days after last dose
Proportion of subjects with clinically significant changes in vital signs:body temperature(°C)
时间窗: Up to 10-14days after last dose
次要结局
未报告次要终点