A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety and Tolerability as measured by number of participants with adverse events
研究概览
简要总结
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet one of the following criteria:Woman aged ≥18 years with histologically proven non-metastatic breast cancer (Stages I, II or III) and without evidence of disease / Woman aged ≥40 years who are post-menopausal / Woman aged ≥40 years who are peri-menopausal
- •Subjects who have ≥7 Vasomotor Symptoms per day on average
- •A body weight of ≥45 kg
排除标准
- •Participation in more than three clinical studies involving administration of an unlicensed Investigational Medicinal Product 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
MT-8554 low dose
Patients who meet eligibility criteria will be administered once daily either low dose of MT-8554 or a matching Placebo from Day 1 to 14.
干预措施: MT-8554 low dose (Drug)
MT-8554 low dose
Patients who meet eligibility criteria will be administered once daily either low dose of MT-8554 or a matching Placebo from Day 1 to 14.
干预措施: Placebo (Drug)
MT-8554 middle dose
Patients who meet eligibility criteria will be administered once daily either middle dose of MT-8554 or a matching Placebo from Day 1 to 14.
干预措施: MT-8554 middle dose (Drug)
MT-8554 middle dose
Patients who meet eligibility criteria will be administered once daily either middle dose of MT-8554 or a matching Placebo from Day 1 to 14.
干预措施: Placebo (Drug)
MT-8554 high dose
Patients who meet eligibility criteria will be administered once daily either high dose of MT-8554 or a matching Placebo from Day 1 to 14.
干预措施: MT-8554 high dose (Drug)
MT-8554 high dose
Patients who meet eligibility criteria will be administered once daily either high dose of MT-8554 or a matching Placebo from Day 1 to 14.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability as measured by number of participants with adverse events
时间窗: Up to Day 21
Safety and Tolerability as measured by vital signs
时间窗: Up to Day 21
次要结局
- Frequency of Vasomotor Symptoms(Up to Day 15)
- Plasma concentration of MT-8554 after dosing(Up to Day 15)
- Change from baseline in core body temperature(Up to Day 14)