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

Vivus

Status and phase: Completed; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: VI-0521; Drug: Placebo; Other: Alcohol; Other: alcohol placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00806260

OB-205

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Treatment 1

Experimental group

Description:

Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo

Treatment:

Drug: VI-0521

Other: Alcohol

Drug: Placebo

Treatment 2

Experimental group

Description:

First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521

Treatment:

Drug: VI-0521

Other: alcohol placebo

Drug: Placebo

Treatment 3

Experimental group

Description:

First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521

Treatment:

Drug: VI-0521

Other: Alcohol

Drug: Placebo

Treatment 4

Experimental group

Description:

First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521

Treatment:

Drug: VI-0521

Other: alcohol placebo

Drug: Placebo