Open label, Phase I study to assess and compare the pharmacokinetic parameters after multiple oral administration of stiripentol 1000 mg in renal impaired patients and matching controls with normal renal function

Start 2 Jun 2023 · End 30 Nov 2024 · Status Ended · 1 EU/EEA countries · 2 sites · Protocol STP237

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 48

Countries 1

Sites 2

Patients with renal impairement

Key facts

Sponsor: Biocodex
Participant type: Patients, Healthy volunteers
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Not possible to specify
Trial duration: 2 Jun 2023 → 30 Nov 2024
Decision date (initial): 2024-11-27
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-516655-40-00
EudraCT number: 2022-002842-42

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Patients with renal impairement

Version	Level	Code	Term	System organ class
22.1	LLT	10009122	Chronic renal impairment	10038359

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Biocodex

Sponsor organisation: Biocodex
Address: 7 Avenue Gallieni
City: Gentilly
Postcode: 94250
Country: France

Scientific contact point

Organisation: Biocodex
Contact name: Laurent Chancharme

Public contact point

Organisation: Biocodex
Contact name: Laurent Chancharme

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Bulgaria	Ended	48	2
Rest of world	—	0	—

Investigational sites

Bulgaria

2 sites · Ended

Medical Center Comac Medical Ltd.

COMAC Medical, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofia