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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Drug: VI-0521
* Drug: Placebo
* Other: Alcohol
* Other: alcohol placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br>Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo | Drug: VI-0521<br>* Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week<br>Drug: Placebo<br>* Placebo daily for 4 weeks<br>Other: Alcohol<br> <br> |
| Experimental: Treatment 2<br>First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521 | Drug: VI-0521<br>* Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week<br>Drug: Placebo<br>* Placebo daily for 4 weeks<br>Other: alcohol placebo<br>* fruit juice<br>|
| Experimental: Treatment 3<br>First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521 | Drug: VI-0521<br>* Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week<br>Drug: Placebo<br>* Placebo daily for 4 weeks<br>Other: Alcohol<br> <br> |
| Experimental: Treatment 4<br>First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521 | Drug: VI-0521<br>* Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week<br>Drug: Placebo<br>* Placebo daily for 4 weeks<br>Other: alcohol placebo<br>* fruit juice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | at breath alcohol levels 0.10%, 0.07%, and 0.04% | 
| 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. | 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. | Hour 2 and Hour 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obesity, coordination, psychomotor