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
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 17 years ago
What is this trial about?
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.
