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

NCT05735951 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

  • Chronic Renal Insufficiency

Interventions

DRUG

STIRIPENTOL oral administration

Oral administration of: * Days 1 and 2: 1000 mg of stiripentol (single dose at the end of breakfast), * Day 3 to Day 14: 1000 mg of stiripentol bis in die (BID) (approximately 12 hours apart, at the end of breakfast and at the end of dinner), * Day 15: 1000 mg of stiripentol (single dose at the end of breakfast).

Sponsors & Collaborators

  • Biocodex

    lead INDUSTRY

Principal Investigators

  • Diyan Genov, MD · Comac Medical

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05735951 on ClinicalTrials.gov