NCT01458899已完成1 期
Phase I, Open-label, Randomized, Single-dose, Two Treatment (Fed Versus Fasted) Crossover Study to Assess the Effects of Food on the Pharmacokinetics of TC-5214 (S-Mecamylamine) in Healthy 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
- 18
- 试验地点
- 1
- 主要终点
- TC-5214 area under the plasma concentration time curve will be measured.
研究概览
简要总结
(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects.
详细描述
Phase I, Open-label, Randomized, Single-dose, Two treatment (Fed Versus Fasted) Crossover Study to Assess the Effects of Food on the Pharmacokinetics of TC-5214 (S-Mecamylamine) in Healthy Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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
- •Provision of signed, written, and dated informed consent prior to any study specific procedures.
- •Healthy male and nonpregnant, nonlactating female 18 to 55 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
- •Have a body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg
- •Be willing to eat the high-calorie, high-fat breakfast or fast accordingly
- •Be able to understand and comply with the requirements of the study as judged by the Investigator
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
- •History of gastrointestinal surgery (except for appendectomy) or unintentional rapid weight loss
- •History of seizure activity, including febrile seizures
- •Past diagnosis of more than 1 episode of major depression
- •History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
研究组 & 干预措施
A - first fed then fasted treatment
Experimental
TC-5214
干预措施: TC-5214 (Drug)
B - first fasted then fed treatment
Experimental
TC-5214
干预措施: TC-5214 (Drug)
结局指标
主要结局
TC-5214 area under the plasma concentration time curve will be measured.
时间窗: Pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose
TC-5214 maximum plasma concentration will be measured
时间窗: Pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose
次要结局
- Description of urine pharmacokinetics (PK) of TC-5214 in terms of the cumulative amount of drug excreted unchanged into urine from zero to time and renal clearance(PK samples collected at pre dose, 0 - 12, 12 - 24, 24 to 48 hours post dose)
- The number of participants with adverse events(During day - 1, day 1, 2, 3 and 4 of treatment period)
- A change from baseline in laboratory assessments(During day - 1 and day 3 of visits 2 and 3 of treatment period)
- A change from baseline in vital signs(During day - 1, day 1, 2, 3 and 4 of treatment period)
- A change from baseline in physical examination(During day -1)
- Description of the pharmacokinetics (PK) of TC-5214 in terms of area under the curve over the time (AUC) and maximum concentration (Cmax) and terminal half-life(PK samles collected at pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose)
研究者
研究点 (1)
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