NCT00366483已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of Lecozotan SR Administered Orally to Healthy Young and Elderly Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The incidence of adverse events and adverse reactions will be calculated. The safety variables (vital signs, ECG parameters, and routine laboratory tests) and PK parameters will be measured throughout study period.
研究概览
简要总结
To assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of lecozotan SR in healthy young and elderly subjects.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young subjects: Men aged 18 to 45 years. -Elderly subjects: Men and women ≥ 65 years of age. -Body mass index in the range of 18 to 30 kg/m2 and body weight ≥ 50 kg. -Healthy as determined by the investigator.
排除标准
- •History of any neuropsychiatric disorder. -History of drug or alcohol abuse.
结局指标
主要结局
The incidence of adverse events and adverse reactions will be calculated. The safety variables (vital signs, ECG parameters, and routine laboratory tests) and PK parameters will be measured throughout study period.
次要结局
- Pharmacokinetic analysis after single and multiple dosing
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-553 in Healthy Volunteers and in Subjects With Psoriasis and Efficacy of ABBV-553 in Subjects With PsoriasisPsoriasisNCT03145948AbbVie12
已完成
1 期
A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese DescentHealthy ParticipantsNCT05546151Bristol-Myers Squibb24
终止
1 期
Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human VolunteersExcessive SleepinessMajor Depressive DisorderNCT04618263Gate Neurosciences, Inc18
已完成
1 期
Phase 1 Study to Assess the Safety/Tolerability of Brexpiprazole as Adjunctive Therapy in Elderly Subjects With Major Depressive DisorderMajor Depressive DisorderNCT01670279Otsuka Pharmaceutical Development & Commercialization, Inc.18
已完成
1 期
Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in HealthyHealthy SubjectsOsteoarthritisNCT00380900Wyeth is now a wholly owned subsidiary of Pfizer