A Drug Interaction Study of VI-0521 With Metformin, Sitagliptan and Probenecid in Healthy Subjects.

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are to:

• Find out how much of the study drugs are in the blood of healthy subjects after taking multiple doses of VI-0521, metformin and sitagliptan.

• Determine the effect of probenecid on the amount of VI-0521 in the blood of healthy subjects after taking multiple doses.

• Find out how much topiramate is in the semen of healthy male subjects after taking multiple doses.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: VIVUS, Inc.
• Treatments: Metformin; Phentermine; Probenecid; Topiramate

Criteria

Inclusion Criteria:

• The study population will consist of adult healthy males or females, 19-45 years of age; inclusive who are medically healthy with no clinically significant screening results.

Exclusion Criteria:

• Main exclusion criteria include a history or presence of significant cardiovascular, neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the Investigator; any clinically significant laboratory abnormalities as judged by the Investigator; any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure; presence of cholelithiasis or cholecystitis within the last 6 months that has not been surgically treated with cholecystectomy; any history of a cardiovascular or cerebrovascular event; any active malignancy except basal cell carcinoma; systolic blood pressure > 150 mm Hg or diastolic blood pressure > 95 mm Hg at screening or at check-in (Two rechecks are allowed); positive drug/alcohol test at screening or check in; blood donation or significant blood loss within 56 days of dosing; plasma donation within 7 days of dosing. In female subjects, a positive pregnancy test at screening or check-in is exclusionary.