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

NCT ID: NCT00806260

Last Updated: 2013-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-05-31

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.

Conditions

Overweight; Obesity

Keywords

Overweight; Obesity; coordination; psychomotor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment 1

Dosed first with alcohol, then active VI-0521, and last, VI-0521 placebo

Group Type: EXPERIMENTAL

VI-0521

Intervention Type: DRUG

Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week

Placebo

Intervention Type: DRUG

Placebo daily for 4 weeks

Alcohol

Intervention Type: OTHER

Treatment 2

First dosed with alcohol placebo (fruit juice), then active VI-0521, and last, placebo VI-0521

Group Type: EXPERIMENTAL

VI-0521

Intervention Type: DRUG

Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week

Placebo

Intervention Type: DRUG

Placebo daily for 4 weeks

alcohol placebo

Intervention Type: OTHER

fruit juice

Treatment 3

First dosed with alcohol, then VI-0521 placebo, and last, active VI-0521

Group Type: EXPERIMENTAL

VI-0521

Intervention Type: DRUG

Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week

Placebo

Intervention Type: DRUG

Placebo daily for 4 weeks

Alcohol

Intervention Type: OTHER

Treatment 4

First dosed with alcohol placebo, then VI-0521 placebo, and last, active VI-0521

Group Type: EXPERIMENTAL

VI-0521

Intervention Type: DRUG

Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week

Placebo

Intervention Type: DRUG

Placebo daily for 4 weeks

alcohol placebo

Intervention Type: OTHER

fruit juice

Interventions

VI-0521

Phentermine 3.75 mg and topiramate 23 mg daily for the 1st week; Phentermine 7.5 mg and topiramate 46 mg daily for the 2nd week; Phentermine 11.25 mg and topiramate 69 mg daily for the 3rd week; Phentermine 15 mg and topiramate 92 mg daily for the 4th week

Intervention Type: DRUG

Placebo

Placebo daily for 4 weeks

Intervention Type: DRUG

Alcohol

Intervention Type: OTHER

alcohol placebo

fruit juice

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MDS Pharma Services

INDUSTRY

Sponsor Role: collaborator

VIVUS LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Peterson

Role: STUDY_DIRECTOR

VIVUS LLC

Alan Marion, MD

Role: PRINCIPAL_INVESTIGATOR

MDS Pharma Services

Locations

Research Site

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

OB-205

Identifier Type: -

Identifier Source: org_study_id