jRCT2071230052进行中（未招募）不适用
Phase I study to investigate the pharmacokinetics, food effect, and safety of AKP-009 after single and multiple oral doses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 81
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 性别
- Male
入选标准
- •Individuals who are capable of understanding the nature of the study and can provide written voluntary consent to participate in the study
- •Healthy adult Japanese men 65 to 85 years of age (inclusive) at the time of informed consent for the multiple-dose 20 mg-H group, and healthy adult Japanese men 20 to 40 years of age (inclusive) at the time of informed consent for the other groups
- •Individuals with a BMI of >= 18.5 and <= 25.0 at screening
排除标准
- •Individuals with current or previous disease considered inappropriate for participation in the study, such as liver disorders, kidney disorders, cerebrovascular/cardiovascular disorders, gastrointestinal disorders, blood diseases, or endocrine diseases
- •Individuals with drug allergy
- •Individuals with current or previous convulsive disorder such as epilepsy
- •Individuals with current or previous alcoholism
- •Individuals who test positive for drug abuse at screening
- •Individuals who test positive for HBs antigen, HCV antibody, HIV antigen/antibody, or serological syphilis at screening
- •Individuals who weigh less than 50 kg at screening
- •Individuals from whom at least 200 mL or 400 mL of blood had been collected within 4 or 12 weeks before study treatment, respectively, or who had donated blood component within 2 weeks before study treatment
- •Individuals who are considered by the investigator/subinvestigator to be unsuitable for participation in the study based on the medication status within 1 week before study treatment
- •Individuals who had participated in another clinical trial within 16 weeks before study treatment
结局指标
主要结局
-
Pharmacokinetics and safety
次要结局
未报告次要终点
研究者
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