Pharmacokinetics of Modified Slow-Release Oral Testosterone Over 10 Days in Normal Men With Experimental Hypogonadism
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Maximum Testosterone Concentration
研究概览
简要总结
The purpose of this study is to test how the body absorbs a new form of oral testosterone (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at the University of Washington to monitor blood testosterone levels over a 24-hour period.
详细描述
We will administer two experimental drugs, acyline and oral testosterone. Acyline shots will be given on Day 0 to turn off the body's testosterone production for about 10-14 days.
The next day, Day 1, subjects begin taking 300 mg modified slow-release testosterone pill by mouth, three times a day, around 9 AM, 1 PM, and 7 PM for a total of 27 pills.
There are overnight stays on Day 1 and Day 9 to allow monitoring of blood testosterone levels over a 24 hour period, from @9 AM to 9 AM the next morning. At those visits, blood is drawn at baseline (before taking the pill) and at 1, 2, 4, 5, 6, 8, 10, 11, 12, 14, 16, and 24 hours after the morning dose.
Acyline is an experimental drug. The FDA allows its use only in research with a small number of volunteers. We have used acyline in over 125 men without serious side effects. The use of testosterone in this study is experimental and there may be unknown or unanticipated risks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Acyline and oral testosterone
干预措施: Oral Testosterone (Drug)
Acyline and oral testosterone
干预措施: Acyline (Drug)
结局指标
主要结局
Maximum Testosterone Concentration
时间窗: baseline & day 9
initial pharmacokinetics \[PK\] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment
Mean Testosterone Concentration
时间窗: baseline & day 9
initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment
次要结局
- Maximum Dihydrotestosterone (DHT) Concentration(baseline & day 9)
- Mean Dihydrotestosterone (DHT) Concentration(baseline & day 9)
- Maximum Sex Hormone-Binding Globulin (SHGB)Concentration(baseline & day 9)
- Mean SHGB Concentration(baseline & day 9)
- Maximum Estradiol Concentration(baseline & day 9)
- Mean Estradiol Concentration(baseline & day 9)
- Free T Maximum Concentration(baseline & day 9)
- Free Testosterone Mean Concentration(baseline & day 9)
研究者
John Amory
Professor
University of Washington