Status:
COMPLETED
A Study to Evaluate How VI-0521 Affect Psychomotor Performance in Healthy Overweight and Obese Subjects.
Lead Sponsor:
VIVUS LLC
Collaborating Sponsors:
MDS Pharma Services
Conditions:
Overweight
Obesity
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00806260
Start Date
December 1 2008
End Date
May 1 2009
Last Update
September 13 2013
Active Locations (1)
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1
Research Site
Lincoln, Nebraska, United States, 68502