A Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

VI-0521, a fixed dose combination of immediate-release (IR) phentermine and controlled-release (CR) topiramate, is in Phase III clinical development as a potential therapy for obesity. In human, both phentermine and topiramate are primarily cleared by renal excretion. The contribution of hepatic metabolism to elimination of phentermine and topiramate is not significant. Obese patients, the proposed indicated population for future treatment with VI-0521, are likely to have renal impairment. Therefore, this study is important in understanding the effect of renal impairment on the pharmacokinetics of topiramate and phentermine in subjects with renal impairment compared to subjects with normal renal function.

Key facts

Study ID

NCT00768404

Run by

VIVUS LLC

People needed

32

Starts

2008-10-01

Expected to finish

2009-07-01

Last updated by the study team

2009-12-01

Who can join

Age: 19 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Group 1 will consist of 8-10 males or females with normal renal function, 19-75 years of age, inclusive.
• Groups 2-4 will consist of 8-10 males or females per group with varying degree of stable renal impairment

You may not qualify if…

• 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 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; subjects requiring dialysis; any active malignancy except basal cell carcinoma; systolic blood pressure > 180 mm Hg or diastolic blood pressure > 100 mm Hg at screening or at check-in (2 rechecks are allowed); Hemoglobin <12.0 g/dL for Group 1 (patients with normal renal function); Hemoglobin <. 9.0 g/dL for Groups 2, 3 and 4 (patients with mild to severe renal function) 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

Where it is running

• Advanced Clinical Research Institute — Anaheim, California, United States
• Clinical Pharmacology of Miami — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• DaVita Clinical Research — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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