Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of K-312 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- CETP activity
研究概览
简要总结
The purpose of this study is to investigate the safety tolerability, and PK profile of K-312 and its metabolites in healthy Japanese and non-Japanese adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject provides written informed consent before any study-specific evaluation is performed.
- •Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive.
- •Subject has a body mass index of 18.5 to 30 kg/m2, inclusive.
- •Subject has hematology, coagulation, serum chemistry, and urinalysis test results within the reference ranges or showing no clinically relevant deviations, as judged by the Investigator.
排除标准
- •Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.
- •Subject has any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of K-
- •Cholecystectomy is permitted if there are no postcholecystectomy gastrointestinal symptoms.
- •Subject has clinically relevant abnormalities in clinical laboratory parameters.
研究组 & 干预措施
Cohort 3
Japanese and Non-Japanese subjects receiving K-312 200 mg QD
干预措施: K-312 200 mg QD (Drug)
Cohort 3
Japanese and Non-Japanese subjects receiving K-312 200 mg QD
干预措施: Placebo (Other)
Cohort 1
Japanese and Non-Japanese subjects receiving K-312 50 mg QD
干预措施: K-312 50 mg QD (Drug)
Cohort 1
Japanese and Non-Japanese subjects receiving K-312 50 mg QD
干预措施: Placebo (Other)
Cohort 2
Japanese and Non-Japanese subjects receiving K-312 100 mg QD
干预措施: K-312 100 mg QD (Drug)
Cohort 2
Japanese and Non-Japanese subjects receiving K-312 100 mg QD
干预措施: Placebo (Other)
Cohort 4
Japanese and Non-Japanese subjects receiving K-312 400 mg QD
干预措施: K-312 400 mg QD (Drug)
Cohort 4
Japanese and Non-Japanese subjects receiving K-312 400 mg QD
干预措施: Placebo (Other)
Cohort 5
Japanese and Non-Japanese subjects receiving K-312 25 mg QD
干预措施: K-312 25 mg QD (Drug)
Cohort 5
Japanese and Non-Japanese subjects receiving K-312 25 mg QD
干预措施: Placebo (Other)
Cohort 6
Japanese and Non-Japanese subjects receiving K-312 10 mg QD
干预措施: K-312 10 mg QD (Drug)
Cohort 6
Japanese and Non-Japanese subjects receiving K-312 10 mg QD
干预措施: Placebo (Other)
结局指标
主要结局
CETP activity
时间窗: Days 1, 3, 6, 11, 16, 21, 27 and 30
Area under the plasma concentration
时间窗: Days 1 and 21
次要结局
未报告次要终点