The current Food and Drug Administration (FDA) draft guidance for renal impairment studies advises performance of a PK study in patients with renal impairment for medications primarily excreted in urine and also for medications primarily metabolized or secreted in bile. The major routes of excretion of bevenopran in animals were identified as hepatobiliary and renal. In addition, preliminary findings show >40% of an oral bevenopran dose is eliminated unchanged in urine over a 48-72 hour period post-dose.~This is a Phase 1, non-randomized, parallel group, open-label study to characterize the effect of renal function on the PK of bevenopran in 1 or more study centers. At screening, eligible subjects will be enrolled and assigned to 1 of 5 parallel study groups of approximately 8 to 12 subjects each based on the classification of the renal function using estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study, as presented in the FDA guidance on renal impairment studies. There are 5 study groups based on eGFRs.
The purpose of this study is to characterize the effect of renal function on the PK of a 0.25 mg single oral dose of bevenopran in humans and to assess the safety and tolerability of bevenopran in patients with varying degrees of renal impairment and in healthy subjects.