A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.

Phase 2

Completed

Conditions: Overweight
Obesity

Interventions: Drug: VI-0521
Drug: Placebo
Other: Alcohol
Other: alcohol placebo

Registration Number: NCT00806260

Lead Sponsor: VIVUS LLC

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment 1	Placebo	Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo
Treatment 1	Alcohol	Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo
Treatment 2	VI-0521	First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521
Treatment 1	VI-0521	Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo
Treatment 2	Placebo	First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521
Treatment 2	alcohol placebo	First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521
Treatment 3	VI-0521	First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521
Treatment 3	Placebo	First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521
Treatment 3	Alcohol	First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521
Treatment 4	Placebo	First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521
Treatment 4	alcohol placebo	First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521
Treatment 4	VI-0521	First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521

Primary Outcome Measures

Name	Time	Method
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.	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.	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.