Status:
COMPLETED
Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ)
Lead Sponsor:
Biocodex
Conditions:
Dravet Syndrome
Epilepsy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a Phase I, open-label, randomized, single-center, two-way cross-over study evaluating the relative bioavailability, pharmacokinetics, safety, and palatability of two formulations of stiripento...
Detailed Description
Stiripentol (Diacomit®) is currently marketed in two dosage forms: capsules (250 and 500 mg) and powder for oral suspension in sachets (250 and 500 mg). The powder formulation was developed for patien...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Aged between 18 and 50 years (inclusive).
- Considered healthy after a comprehensive clinical assessment (medical history + complete physical exam).
- Body Mass Index (BMI) between 18 and 30 kg/m² (inclusive) and body weight ≥ 50 kg at screening.
- Normal blood pressure (BP) and heart rate (HR) after 10 minutes supine at screening : Systolic BP: 90-145 mmHg, Diastolic BP: 45-90 mmHg, HR: 40-90 bpm, Or values outside these ranges but judged not clinically significant (NCS) by the Investigator.
- Normal ECG at screening (10-min resting 12-lead ECG): PR interval: 110-210 ms, QRS interval : \< 120 ms, QTcF interval: ≤ 450 ms, No evidence of sinus node dysfunction, Or values outside these ranges but judged NCS by the Investigator.
- Laboratory parameters within normal ranges (hematology, biochemistry, urinalysis); slight deviations allowed if not clinically relevant per Investigator.
- Women of non-childbearing potential, or women of childbearing potential using at least one acceptable contraceptive method throughout the study and 1 month after last treatment.
- Female subjects of childbearing potential: negative pregnancy test (serum or urine) at screening and Day 0.
- Covered by Health Insurance System and/or compliant with National Law requirements for biomedical research.
- Able and willing to comply with study requirements.
- Written informed consent obtained.
- Exclusion Criteria
- Unsuitable veins for repeated venipuncture.
- Relevant history/presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease.
- Evidence of any clinically significant acute or chronic disease.
- History of suicidal ideation or suicide attempt.
- Surgery (including clinical trial procedures) within 2 months before dosing.
- Blood donation within 2 months before dosing.
- History/presence of drug hypersensitivity, asthma, or allergy.
- Known hypersensitivity to study materials or related compounds.
- Inability/difficulty swallowing capsules.
- No possibility of emergency contact.
- Any drug intake (except paracetamol) within 4 weeks prior to dosing or \< 5 half-lives (whichever longer). Prohibited: carbamazepine, phenytoin, phenobarbital, CYP enzyme modulators.
- Use of herbal products affecting CYP enzymes within 2 weeks or \< 5 half-lives before dosing.
- Special diets (vegetarian, vegan, gluten-free).
- Vigorous exercise from 4 days before dosing until post-study assessments.
- Pregnant or breastfeeding women.
- Drug/alcohol abuse history, daily alcohol intake \> 4 drinks, or positive alcohol test.
- Excessive xanthine beverages (\> 5 cups/day).
- Nicotine use \> 5 cigarettes/day or inability to abstain 48h before and during study.
- Intake of grapefruit/Seville oranges/poppy seed or other CYP modulators 1 week before dosing and during study.
- Intake of methylxanthines (coffee, tea, cola, cocoa, mate, guarana, chocolate) or quinine (e.g., tonic water) from 48h before dosing and during study.
- Unable/unwilling to follow diet requirements (see protocol section 10.7).
- Positive test for HBsAg, HCV antibody, or HIV 1/2.
- Positive drug screen.
- Significant biological or clinical abnormalities judged incompatible with study.
- Participation in another interventional trial during exclusion period or investigational product within last 60 days or \< 5 half-lives.
- Under guardianship, curatorship, or deprived of liberty.
- Under Court protection.
- Would exceed €6000 compensation for biomedical research in last 12 months (including this study).
- Health status not allowing provision of informed consent.
Exclusion
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2025
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07176832
Start Date
June 1 2025
End Date
August 27 2025
Last Update
September 16 2025
Active Locations (2)
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1
3 Chemin d'Armancourt
Compiègne, France, 60200
2
EUROFINS OPTIMED, 1 rue des Essarts
Gières, France, 38610