NCT01366339已完成1 期
A Replicate Design, Double-Blind, Randomized, Placebo-Controlled Tolerance and Pharmacokinetics Study of N-Methylnaltrexone Tablets in Normal, Healthy Volunteers
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
- 37
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of oral doses of MNTX
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, phase I study in normal healthy volunteers. Study treatment includes single doses of MNTX and placebo. In addition, half of each active treatment group is further randomized to a second, replicate dose of MNTX, and the placebo group receives an additional placebo dose.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Weight between 55 and 85 kg
- •In good health with no evidence of a clinically significant chronic medical condition
- •Non-Smokers.
排除标准
- •History of asthma, allergic skin rash, significant allergy or other immunologic disorder
- •Known or suspected hypersensitivity to opioids or opioid antagonists
- •History or suspicion of alcohol or drug abuse.
研究组 & 干预措施
Arm 1
Experimental
Oral methylnaltrexone
干预措施: Oral methylnaltrexone (Drug)
Arm 2
Experimental
Oral methylnaltrexone
干预措施: Oral methylnaltrexone (Drug)
Arm 3
Experimental
Oral methylnaltrexone
干预措施: Oral methylnaltrexone (Drug)
Arm 4
Placebo Comparator
Oral placebo
干预措施: Oral placebo (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of oral doses of MNTX
时间窗: 7 days
To determine PK, dose proportionality, and urinary excretion of single, oral doses of MNTX in normal healthy volunteers
次要结局
- Half-life of oral doses of MNTX(7 days)
- Peak Time of Maximum Concentration (Tmax) of oral doses of MNTX(7 days)
- Area Under the Plasma Concentration versus Time Curve (AUC) of oral doses of MNTX(7 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of J147Alzheimer's DiseaseNCT03838185Abrexa Pharmaceuticals, Inc.64
已完成
1 期
Effects of CSL324 in the Lung After Segmental ChallengeHealthy VolunteersNCT05653713CSL Behring40
撤回
1 期
Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic EsophagitisEosinophilic EsophagitisNCT04835168NImmune Biopharma
已完成
1 期
Study of DTRI-031 in Healthy VolunteersHealthy VolunteersPharmacokineticsPharmacodynamicsNCT05005520Basking Biosciences, Inc.46
已完成
1 期
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous NafithromycinHealthyNCT03981887Wockhardt10