NCT01476267已完成1 期
An Open Label, Single Centre Study to Investigate the Metabolic Profile of Dalcetrapib After a Single Oral Dose in Healthy Male Subjects
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
- 6
- 主要终点
- Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma
研究概览
简要总结
This single center, open-label, non-randomized, one-treatment, one-period study will evaluate the metabolic profile and the safety of a single oral radiolabeled dose of dalcetrapib in male healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects, 45 to 65 years of age inclusive
- •Body mass index (BMI) between 18 and 32 kg/m2 inclusive
排除标准
- •Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the subject
- •Clinically significant abnormal laboratory values
- •Infrequent bowel movements (e.g. less than one movement per 24 h on average)
- •An intent to father children within 3 months of dosing
- •Any external or internal radiotherapy with open (nuclear medicine) or sealed sources (brachy therapy)
- •External irradiation (radiological examination) or internal radiation (diagnostic nuclear medicine procedure) within one year before study drug dosing; dental radiography and plain X-rays of the extremities are allowed before dosing
研究组 & 干预措施
Single Arm
Experimental
干预措施: dalcetrapib (Drug)
结局指标
主要结局
Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma
时间窗: up to Day 5
次要结局
- Correlation of Metabolic Profile With Enzyme/Transporter Genotypes(approximately 3 months)
研究者
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