NCT02881294已完成1 期
A Phase I, Single-center, Open-label, Single-dose Study to Evaluate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of Orally Administered SUVN-G3031 in Healthy 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
- 24
- 试验地点
- 1
- 主要终点
- Area under concentration (AUC)
研究概览
简要总结
The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive) for food and gender effect
- •Healthy male aged 60 to 70 years with a BMI between 18 and 32 kg/m2, (inclusive) for age effect
排除标准
- •History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
- •Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the study drug.
- •Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody
- •History of any important clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
研究组 & 干预措施
Food Effect
Active Comparator
SUVN-G3031 tablets single dose
干预措施: SUVN-G3031 (Drug)
Gender Effect
Active Comparator
SUVN-G3031 tablets single dose
干预措施: SUVN-G3031 (Drug)
Age Effect
Active Comparator
SUVN-G3031 tablets single dose
干预措施: SUVN-G3031 (Drug)
结局指标
主要结局
Area under concentration (AUC)
时间窗: 96 hours
Maximum observed concentration (Cmax)
时间窗: Day 1
次要结局
未报告次要终点
研究者
研究点 (1)
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