Renal Impairment Clinical Trial
Official title:
Phase 1, Non-Randomized, Parallel-Group, Open-Label Study to Characterize the Pharmacokinetics of a Single Oral Dose of Bevenopran in Patients With Varying Degrees of Renal Impairment Compared to Healthy Subjects
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.
The current Food and Drug Administration (FDA) draft guidance for renal impairment studies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.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
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