NCT00447811已完成1 期
Two Ascending Single Doses Crossover, Placebo Controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MOA-728 Administered Orally to Subjects on Stable Methadone Maintenance
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MOA-728 in subjects on stable methadone maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of methadone treatment for at least 1 month before day -1 at a dose of ≥ 30 mg/day, and a positive drug test result for methadone.
- •Healthy as determined by the investigator on the basis of screening evaluations.
排除标准
- •Allergy to opioids (eg, codeine, morphine, or oxymorphone) or opioid antagonists (eg, naloxone or naltrexone).
- •Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
结局指标
主要结局
Pharmacokinetics
次要结局
- Safety, tolerability, and pharmacodynamics
研究者
研究点 (1)
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