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

PHASE1CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

July 24, 2023

Primary Completion Date

November 30, 2024

Study Completion Date

November 30, 2024

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)."

Trial Locations (1)

1612

Mc Comac Medical, Sofia

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocodex

INDUSTRY