NCT07176832CompletedPhase 1
Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ)
Bioavailability Study of Stiripentol After Single Oral Administration of Two Different Formulations (Capsule and Oral Suspension) in 24 Healthy Subjects
Source: ClinicalTrials.gov · Last updated 16 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 stiripentol (Diacomit®), indicated in Dravet syndrome. The investigational products are 500 mg capsules (reference) and a 50 mg/mL oral suspension (test). The primary objective is to compare the relative bioavailability of the two formulations after a single 1,000 mg oral dose under fed conditions, based on Cmax, AUC0-t, and AUC0-∞. Secondary objectives include other PK parameters (tmax, tlag, ke, t1/2) and characterization of metabolites MIa and MIb. Palatability of the suspension will be assessed by questionnaire. Safety evaluation will include adverse events, laboratory tests, ECGs, urinalysis, drug and alcohol screening, serology, and vital signs. Twenty-four healthy volunteers (18-50 years) will be enrolled. Eligibility: BMI 18-30 kg/m², weight ≥50 kg, normal ECG and labs, and informed consent. Women of childbearing potential must use effective contraception and test negative for pregnancy. Exclusions: significant disease, recent surgery or blood donation, hypersensitivity, difficulty swallowing, use of CYP modulators (e.g., carbamazepine, grapefruit, herbal products), drug or alcohol abuse, smoking \>5 cigarettes/day, or inability to follow dietary restrictions. Subjects testing positive for HIV, HBV, HCV, or drugs of abuse will also be excluded. Each participant will attend a screening visit within 28 days before dosing, then two 3-day hospitalizations separated by a 7-15-day washout. On Day 1 of each period, they will receive either two capsules (1,000 mg) or 20 mL suspension (1,000 mg). Blood will be collected at 36 timepoints (≈180 mL total) for PK assessment. The total study duration per subject is about seven weeks, including screening, hospitalization, dosing, washout, and follow-up. Treatment consists of one dosing day per period. Sample size was based on prior data: 21 pairs provide 80% power for bioequivalence within 0.80-1.25 bounds; 24 subjects will be recruited to account for dropouts. Analyses will include the Safety Set, PK Concentrations Set, and PK Analysis Set. This trial aims to establish whether the oral suspension provides a PK profile comparable to capsules, while generating safety, tolerability, and palatability data to support a more convenient formulation for Dravet syndrome patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 29 Aug 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 27 Aug 2025
- Lead sponsor
- Biocodex
- Diseases
- Epilepsy
- NCT number
- NCT07176832
- EU CT number
- 2024-520103-38-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 24
- From 1 Jun 2025 to the primary completion date, 27 Aug 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgery (including clinical trial procedures) within 2 months before dosing.
- Blood donation within 2 months before dosing.
- Any drug intake (except paracetamol) within 4 weeks prior to dosing or \< 5 half-lives (whichever longer). Prohibited: carbamazepine, phenytoin, phenobarbital, CYP enzyme modulators.
- Vigorous exercise from 4 days before dosing until post-study assessments.
- Drug/alcohol abuse history, daily alcohol intake \> 4 drinks, or positive alcohol test.
- Intake of grapefruit/Seville oranges/poppy seed or other CYP modulators 1 week before dosing and during study.
- Positive drug screen.
- Participation in another interventional trial during exclusion period or investigational product within last 60 days or \< 5 half-lives.
Other illness
- 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.
- History/presence of drug hypersensitivity, asthma, or allergy.
- Known hypersensitivity to study materials or related compounds.
- Positive test for HBsAg, HCV antibody, or HIV 1/2.
Other
- Unsuitable veins for repeated venipuncture.
- Inability/difficulty swallowing capsules.
- No possibility of emergency contact.
- Use of herbal products affecting CYP enzymes within 2 weeks or \< 5 half-lives before dosing.
- Special diets (vegetarian, vegan, gluten-free).
- Pregnant or breastfeeding women.
- Excessive xanthine beverages (\> 5 cups/day).
- Nicotine use \> 5 cigarettes/day or inability to abstain 48h before 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).
- Significant biological or clinical abnormalities judged incompatible with study.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 3 Chemin d'Armancourt Coordinator of this site? Confirm its status | Compiègne | France | Unknown status |
| EUROFINS OPTIMED, 1 rue des Essarts Coordinator of this site? Confirm its status | Gières | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.