jRCT2080222333未知1 期
Open-label study to assess safety, pharmacokinetics and exposed dose of NMK20 in healthy Japanese male subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 6
- 主要终点
- Assessment of subjective/objective symptoms
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Uncontrolled, Single-dose, Open-label
入排标准
- 年龄范围
- 20age old over 至 64age old under（—）
- 性别
- Male
入选标准
- •Body weight: 50.0 kg or more
- •Body mass index: 18.5 and more - 25.0 below
排除标准
- •Subjects with abnormality found by liver function test or renal function test.
- •Subjects with a hypersensitive history to drugs or foods.
- •Subjects who have abused or are abusing drugs.
- •Subjects who were or are addicted to alcohol.
- •Subjects who have received an investigational new drug other than NMK20 from six months before screening up to hospital admission.
结局指标
主要结局
Assessment of subjective/objective symptoms
Assessment of subjective/objective symptoms
Electrocardiogram exams
Electrocardiogram exams
Vital signs
Vital signs
Clinical tests
Clinical tests
次要结局
- Assessment of radioactivity in blood, radioactivity distribution rate in organs/tissue and urinary excretion rate of radioactivity
- Assessment of unchanged drug and radioactive metabolites in blood plasma and urine
- Calculation of exposed dose by medical internal radiation dose(MIRD) method
研究者
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