NCT01766167已完成1 期
Clinical Pharmacology Study of MP-424 in Healthy Male Adult Volunteers (Single- and Multiple-Dose Study)
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
- 26
- 主要终点
- MP-424 area under the plasma concentration-time curve (AUC) from 0 to infinity in Korean healthy volunteers
研究概览
简要总结
To conduct the following evaluations in Korean healthy male adult volunteers receiving a single and multiple doses of MP-424 tablets:
- Pharmacokinetics of MP-424 after a single and multiple doses.
- Safety and tolerability of single and multiple doses of MP-424.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Korean healthy male volunteers aged 20 to 55 years
排除标准
- •Subjects with a BMI of <18.5 or >25.0, or body weight of <50kg at prior examination
- •Subjects who have had surgery that is known to affect gastrointestinal absorption of drugs (except for appendectomy and hernia surgery)
- •Subjects who have had any evidence of cardiac disease at prior examination or who have a previous history of cardiac disease
- •Subjects who are positive for HBs antigen, serologic tests for syphilis, HCV antibody, or HIV antibody at prior examination
- •Subjects who have experienced symptoms of alcohol abuse or excessive alcohol ingestion
- •Subjects who test positive on urinalysis for drug use (amphetamine, benzodiazepine, barbiturates, cannabinoid, cocaine, opiates, and methadone) at prior examination
- •Subjects who do not agree to use a physical contraceptive method during the study period
- •Subjects who do not agree to use contraceptive methods for 90 days after final administration of the study drug
- •Subjects who have consumed grapefruit, Seville orange, star fruit, cranberry, or any processed food containing these fruits within 7 days before the commencement of study drug administration
- •Subjects who have consumed health foods containing St John's Wort within 2 weeks before study drug administration
研究组 & 干预措施
MP-424
Experimental
干预措施: MP-424 (Drug)
结局指标
主要结局
MP-424 area under the plasma concentration-time curve (AUC) from 0 to infinity in Korean healthy volunteers
时间窗: up to 1 week
Number of participants with adverse events as a measure of safety and tolerability in Korean healthy volunteers
时间窗: up to 2 week
次要结局
未报告次要终点
研究者
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