NCT01040637已完成1 期
A Phase 1/Phase 2, Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Effect on Opioid Analgesia of TD-1211 Administered Orally to Healthy Volunteers and to Assess the Safety, Pharmacokinetics, and Effect on Bowel Movements in Subjects With Opioid-Induced Constipation
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
- 102
- 试验地点
- 4
- 主要终点
- Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).
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
- Double (Participant, Investigator)
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
- •Males and females between 18 and 65 years of age, inclusive
- •Healthy subjects and subjects with documented OIC on stable opioid regimen
- •Willingness to stop all laxatives throughout the OIC screening and treatment period
排除标准
- •Any clinically significant finding in healthy subjects
- •Have participated in another clinical trial of an investigational drug 30 days prior to screening
- •History of chronic constipation prior to opioid therapy in OIC subjects
- •Active medical disorders associated with diarrhea or intermittent loose stools in OIC subjects
研究组 & 干预措施
Placebo
Placebo Comparator
Ascending doses
干预措施: Placebo (Drug)
TD-1211 dose level 4
Experimental
Ascending doses
干预措施: TD-1211 (Drug)
TD-1211 OIC dose level 5
Experimental
Ascending doses
干预措施: TD-1211 (Drug)
TD-1211 OIC dose level 1
Experimental
Ascending doses
干预措施: TD-1211 (Drug)
TD-1211 dose level 1
Experimental
Ascending doses
干预措施: TD-1211 (Drug)
TD-1211 dose level 2
Experimental
Ascending doses
干预措施: TD-1211 (Drug)
TD-1211 dose level 3
Experimental
Ascending doses
干预措施: TD-1211 (Drug)
TD-1211 OIC dose level 2
Experimental
Ascending doses
干预措施: TD-1211 (Drug)
TD-1211 OIC dose level 3
Experimental
Ascending doses
干预措施: TD-1211 (Drug)
TD-1211 OIC dose level 4
Experimental
Ascending doses
干预措施: TD-1211 (Drug)
结局指标
主要结局
Safety and tolerability in healthy subjects and activity in subjects with opioid-induced constipation
时间窗: Daily pre and post dose assessments throughout the duration of the study period
次要结局
- Evaluation of the multiple dose pharmacokinetics of TD-1211 following oral administration(Daily pre and post dose assessments throughout the duration of the study period)
研究者
研究点 (4)
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