drugset / Trial / NCT05735951

Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function

NCT05735951

Phase 1 Completed 39 enrolled Biocodex
Non-randomizedSequentialOpen-labelOther

Summary

The purpose of this study is to determine whether the pharmacokinetics (PK) of stiripentol and of its relevant metabolites would be altered in subjects with renal impairment compared with normal controls in order to assess the need of dose adjustment in the renal impaired population. This study will include subjects with mild, moderate and severe renal impairment.

Timeline

Start
2023-07-24
Primary completion
2024-11-30
Completion
2024-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Stiripentol Small molecule 1000 mg Oral