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Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers

NCT03866928 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-12-20

No results posted yet for this study

Summary

This is a monocentric open label study to assess the PK parameters of stiripentol and its metabolites (if any are detected) after multiple oral doses in 14 healthy male subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Stiripentol

1500 mg of stiripentol b.i.d.

Sponsors & Collaborators

  • Biocodex

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2019-04-05
Completion
2019-04-05

Countries

  • Belgium

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 NCT03866928 on ClinicalTrials.gov