A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.
Completed · Phase 2 · Has a placebo group
Conditions studied: Overweight, Obesity
In brief
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.
Key facts
- Study ID
- NCT00806260
- Run by
- VIVUS LLC
- People needed
- 80
- Starts
- 2008-12-01
- Expected to finish
- 2009-05-01
- Last updated by the study team
- 2013-09-13
Who can join
Age: 21 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Research Site — Lincoln, Nebraska, United States
Full record on ClinicalTrials.gov
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