NCT01145768已完成1 期
A Phase 1, Single Center, Double-blind, Randomized, Placebo- Controlled, Parallel-group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral TC-5214 (S-Mecamylamine) After Administration of Single and Multiple Ascending Doses for up to 8 Days in Healthy Male and Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- safety and tolerability assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical lab assessments, physical exams, neurological exams, suicidality evaluations, visual acuity tests and digital ECGs
研究概览
简要总结
To investigate the safety and tolerability of TC-5214 following oral administration of single and multiple ascending doses compared to placebo.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and nonpregnant, nonlactating female, with suitable veins for cannulation or repeated venipuncture
- •Contraceptive use from the first dose of investigational product until12 weeks after their last dose
- •Body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg
排除标准
- •History of any clinically significant medical, neurologic or psychiatric disease or disorder which, in the opinion of the Investigator and Sponsor, may either put the volunteer at risk because of participation in the study, or influence the results of
- •History of gastrointestinal surgery (except for cholecystectomy and appendectomy) or unintentional rapid weight loss
- •Volunteers with a history of suicide attempts in the past year and/or seen by the Investigator as having a significant history of risk of suicide or homicide, or considered at risk for suicide or homicide during the study
研究组 & 干预措施
1
Experimental
Each cohort will have 9 volunteers that will receive TC-5214
干预措施: TC-5214 (Drug)
2
Placebo Comparator
Each cohort will have 3 volunteers that will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
safety and tolerability assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical lab assessments, physical exams, neurological exams, suicidality evaluations, visual acuity tests and digital ECGs
时间窗: Collected prior to treatment, during treatment and for 7-10 days following discharge. Volunteers will be monitored througout the study for adverse events.
次要结局
- To characterize the pharmacokinetics of TC-5214 in blood and urine after single and repeated oral doses by collecting blood and urine samples to measure drug concentration levels(Blood sampling, every in house day; urine collection ;Days -1 through Day 6, Days 8 through 11.)
- To assess the effect of food on the pharmacokinetics of TC-5214 following oral administration by collecting blood and urine samples to measure drug concentration levels.(Samples taken during the residential period at defined timepoints pre-dose and post-dose)
研究者
研究点 (1)
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