A Randomized Double-Blind, Placebo-controlled Dose Escalating Study of the Pharmacokinetics, Safety and Tolerability of Testosterone Undecanoate (ABT-SLV361) in Hypogonadal Males
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 试验地点
- 1
- 主要终点
- To determine the pharmacokinetics of testosterone after multiple oral doses of ABT-SLV361 in hypogonadal males
研究概览
简要总结
Phase 1 Dose Escalating Study of the safety, tolerability and pharmacokinetics of testosterone in hypogonadal males.
详细描述
M12-778 is a rising multiple dose, randomized, double blind, placebo controlled single center study. It will have 5 dose groups of 20 subjects in dose groups 1,2 and 3 and 24 subjects in dose groups 4 and 5; a total of 84 subjects . There will be a 7 day period between dose groups 1,2 and 3 to assess the safety of increasing to the next dose. Dose groups of 4 and 5 will be run in parallel. Subjects will be confined in center for 20 days for dose groups 1,2 and 3 and 33 days for dose groups 4 and 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Testosterone undecanoate
干预措施: ABT-SLV361 (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
To determine the pharmacokinetics of testosterone after multiple oral doses of ABT-SLV361 in hypogonadal males
时间窗: During confinement
Blood sample results for testosterone
次要结局
- To determine the pharmacokinetic of testosterone undecanoate after multiple oral doses of ABT-SLV361 in hypogonadal males(During confinement)