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

Sponsored by VIVUS LLC

About this trial

Last updated 13 years ago

Study ID

OB-205

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

21 to 45 Years
All Sexes

Trial Timing

Ended 17 years ago

What is this trial 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.

What are the participation requirements?

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.