NCT02267902Unknown1 期
A Phase I, Open-Label, 2-Part Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism and Excretion of DA-1229 in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- the absolute bioavailability of DA-1229 (F)
研究概览
简要总结
The objectives of this study are to evaluate the absolute bioavailability, and absorption and excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral and IV PK of DA-1229 will also be evaluated. The metabolism of DA-1229 may also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Age 18 to 55
- •BMI 18.0 to 30.0 kg/㎡
排除标准
- •History of any drug or alcohol abuse in the past 2years
- •Regular alcohol consumption nin males >21 units per week
- •Current smokers and those who have smoked within the last 12months
- •Radiation Exposure
- •Positive drugs of abuse test result
- •Positive HBsAg, HCV Ab, HIV results
- •Serious adverse reaction or hypersensitivity to any drug of the formulation excipients
- •Clinically significant allergy
- •Donation of loss of blood within the previous 3 months
- •Taking any prescribed or OTC drug or herbal remedies in the 14days before IMP administration
研究组 & 干预措施
Part 2
Experimental
Single oral therapeutic dose of 5mg [14C]-DA-1229
干预措施: DA-1229 (Drug)
Part 1
Experimental
Single oral therapeutic dose of 5mg DA-1229 as a tablet + An IV dose of 20㎍ [14C]-DA-1229
干预措施: DA-1229 (Drug)
结局指标
主要结局
the absolute bioavailability of DA-1229 (F)
时间窗: 240 hours
The mass balance recovery (Ae, %Ae)
时间窗: 240 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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