A Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
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.