A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test
研究概览
简要总结
The purpose of this study is to investigate the pharmacodynamic effect of single doses of MT-8554 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy and free from clinically significant illness or disease
- •Male Caucasian subjects aged 18 to 55
- •A body weight of ≥60 kg
排除标准
- •Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks.
- •Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder.
- •Clinically relevant abnormal medical history, physical findings or laboratory values
研究组 & 干预措施
Regimen 1
Period 1: MT-8554 low dose, Period 2: MT-8554 high dose, Period 3: Placebo and Period 4: Oxycodone hydrochloride, respectively single dosing
干预措施: MT-8554 low dose (Drug)
Regimen 1
Period 1: MT-8554 low dose, Period 2: MT-8554 high dose, Period 3: Placebo and Period 4: Oxycodone hydrochloride, respectively single dosing
干预措施: MT-8554 high dose (Drug)
Regimen 1
Period 1: MT-8554 low dose, Period 2: MT-8554 high dose, Period 3: Placebo and Period 4: Oxycodone hydrochloride, respectively single dosing
干预措施: Oxycodone hydrochloride (Drug)
Regimen 1
Period 1: MT-8554 low dose, Period 2: MT-8554 high dose, Period 3: Placebo and Period 4: Oxycodone hydrochloride, respectively single dosing
干预措施: Placebo (Drug)
Regimen 2
Period 1: MT-8554 high dose, Period 2: Oxycodone hydrochloride, Period 3: MT-8554 low dose and Period 4: Placebo, respectively single dosing
干预措施: MT-8554 low dose (Drug)
Regimen 2
Period 1: MT-8554 high dose, Period 2: Oxycodone hydrochloride, Period 3: MT-8554 low dose and Period 4: Placebo, respectively single dosing
干预措施: MT-8554 high dose (Drug)
Regimen 2
Period 1: MT-8554 high dose, Period 2: Oxycodone hydrochloride, Period 3: MT-8554 low dose and Period 4: Placebo, respectively single dosing
干预措施: Oxycodone hydrochloride (Drug)
Regimen 2
Period 1: MT-8554 high dose, Period 2: Oxycodone hydrochloride, Period 3: MT-8554 low dose and Period 4: Placebo, respectively single dosing
干预措施: Placebo (Drug)
Regimen 3
Period 1: Placebo, Period 2: MT-8554 low dose, Period 3: Oxycodone hydrochloride and Period 4: MT-8554 high dose, respectively single dosing
干预措施: MT-8554 low dose (Drug)
Regimen 3
Period 1: Placebo, Period 2: MT-8554 low dose, Period 3: Oxycodone hydrochloride and Period 4: MT-8554 high dose, respectively single dosing
干预措施: MT-8554 high dose (Drug)
Regimen 3
Period 1: Placebo, Period 2: MT-8554 low dose, Period 3: Oxycodone hydrochloride and Period 4: MT-8554 high dose, respectively single dosing
干预措施: Oxycodone hydrochloride (Drug)
Regimen 3
Period 1: Placebo, Period 2: MT-8554 low dose, Period 3: Oxycodone hydrochloride and Period 4: MT-8554 high dose, respectively single dosing
干预措施: Placebo (Drug)
Regimen 4
Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing
干预措施: MT-8554 low dose (Drug)
Regimen 4
Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing
干预措施: MT-8554 high dose (Drug)
Regimen 4
Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing
干预措施: Oxycodone hydrochloride (Drug)
Regimen 4
Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test
时间窗: up to 10 hours post dosing
次要结局
- Safety and Tolerability as measured by physical examination(up to Day6 of treatment period 4)
- Safety and Tolerability as measured by ECG(up to Day6 of treatment period 4)
- Safety and Tolerability as measured by vital signs(up to Day6 of treatment period 4)
- Safety and Tolerability as measured by laboratory safety assessments(up to Day6 of treatment period 4)
- Plasma concentration of Oxycodone hydrochloride at the time of Pharmacodynamic assessments(up to 10 hours post dosing)
- Safety and Tolerability as measured by number of participants with adverse events(up to Day6 of treatment period 4)
- Plasma concentration of MT-8554 at the time of Pharmacodynamic assessments(up to 10 hours post dosing)