A Phase 2, Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Psychomotor Effect of VI-0521 in Healthy Overweight and Obese Subjects.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With Alcohol Compared to Alcohol Placebo in Period 1.
研究概览
简要总结
The purpose of this study is to determine how VI-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.
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
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written consents;
- •Adequate contraception from screening through 28 days after the last dose of study drug for female subjects;
- •Healthy obese or overweight subjects with BMI between 27 and 35.
排除标准
- •History of glaucoma or any past or present use of medications to treat increased intraocular pressure;
- •Current use of any tobacco products, including cigarettes, cigars, pipes, or chewing tobacco, or use within the three months prior to screening;
- •History of drug abuse during the three years prior to screening;
- •History of alcohol abuse, or excessive alcohol consumption, or describes themselves as non-users of alcohol;
- •Current depression of moderate or greater severity, or any presence or history of suicidal behavior or active suicidal ideation
- •More than one lifetime episode of major depression;
- •Currently working night shifts at a job;
- •On average consumes greater than two cups of coffee or xanthine-containing beverages per day (>200 mg/day) within the two weeks prior to screening;
- •Any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins) within one month prior to screening;
- •Aspartate aminotransferase or alanine aminotransferase >2.5 x ULN;
- •Serum creatinine ≥1.5 mg/dL for men or ≥1.4 mg/dL for women.
研究组 & 干预措施
Treatment 1
Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo
干预措施: VI-0521 (Drug)
Treatment 1
Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo
干预措施: Placebo (Drug)
Treatment 1
Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo
干预措施: Alcohol (Other)
Treatment 2
First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521
干预措施: VI-0521 (Drug)
Treatment 2
First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521
干预措施: Placebo (Drug)
Treatment 2
First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521
干预措施: alcohol placebo (Other)
Treatment 3
First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521
干预措施: VI-0521 (Drug)
Treatment 3
First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521
干预措施: Placebo (Drug)
Treatment 3
First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521
干预措施: Alcohol (Other)
Treatment 4
First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521
干预措施: VI-0521 (Drug)
Treatment 4
First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521
干预措施: Placebo (Drug)
Treatment 4
First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521
干预措施: alcohol placebo (Other)
结局指标
主要结局
Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With Alcohol Compared to Alcohol Placebo in Period 1.
时间窗: at breath alcohol levels 0.10%, 0.07%, and 0.04%
CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are: (a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy \[PFNACC\]); and (c) a coordination measure indicating the respondent's proximity to the center of the target numbers and letters (PF Number Coordination \[PFNCOOR\]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning. The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment.
Measure of Psychomotor Function Using Speed and Coordination on the CogScreen Pathfinder Number (PFN) Test in Subjects Treated With VI-0521 Compared to Placebo in Periods 2 and 3.
时间窗: Hour 2 and Hour 6
CogScreen-Psychomotor Edition (CogScreen-PM) consists of a series of computerized cognitive tasks, each self-contained and presented with instructions and a practice segment. The test battery takes about 20-25 minutes to perform. Performance on the test will be measured as the median reaction time for correct responses (PFNRTC) and coordination errors (PFNCOOR) before and after treatment. The measures of the tests are: (a) response speed, the median response time to complete each sequential step (PFNRTC); (b) response accuracy (PF Number Accuracy \[PFNACC\]); and (c) a coordination measure indicating the respondent's proximity to the center of the target numbers and letters (PF Number Coordination \[PFNCOOR\]). PF measures number sequencing skills, immediate memory, psychomotor speed and coordination, and visual scanning. The normal range for PFN scores is 1.17-2.16. Scores that are higher than this range indicate some level of psychomotor impairment.
次要结局
未报告次要终点