A Randomized, Double-blind, Placebo Controlled, Two Period Crossover Study to Investigate the Pharmacokinetics, Tolerability and Cognitive Effects of an Oral Dose Regimen of 150mg Tid CNV1014802 in Healthy Young Versus Elderly Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Minimum concentration
研究概览
简要总结
A randomized, double-blind, placebo controlled, two period crossover study to investigate the pharmacokinetics, tolerability and cognitive effects of 8 days dosing of CNV1014802 in healthy young versus elderly male and female subjects. Treatment periods will be separated by 13 days. The primary outcome measures are pharmacokinetics (PK) and tolerability.
详细描述
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Healthy male and female over 18 years using acceptable methods of contraception
排除标准
- •Positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody
- •History or evidence of alcohol or drug abuse
- •Pregnant or lactating females
- •Participation in a clinical trial within 3 months or the current study or exposure to more than four new chemical entities within 12 months.
- •Use of prohibited concomitant medication
- •History or presence of any clinically significant abnormality in vital signs / ECG / laboratory tests, or have any medical or psychiatric condition, which, in the opinion of the Investigator may interfere with the study procedures or compromise subject safety.
- •Relevant history of a suicide attempt or suicidal behavior
- •Note: Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
CNV1014802
CNV1014802 150mg three times a day (tid) 7 days plus a single dose on day 8
干预措施: CNV1014802 (Drug)
Placebo
Placebo tid 7 days plus a single dose on day 8
干预措施: Placebo (Drug)
结局指标
主要结局
Minimum concentration
时间窗: 9 days
Maximum Concentration
时间窗: 9 days
Area under the concentration curve
时间窗: 9 days
Frequency of adverse events
时间窗: 9 days
Change in vital signs compared to baseline
时间窗: 9 days
Change in 12-lead ECG parameters compared to baseline
时间窗: 9 days
Change in safety lab parameters compared to baseline
时间窗: 9 days
次要结局
未报告次要终点