Overview

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

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
VIVUS, Inc.
Collaborator:
MDS Pharma Services
Treatments:
Ethanol
Criteria
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.