Dravet SyndromePhase 1STILIQNCT07176832
Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ)
A Phase 1 study testing Stiripentol capsule (Diacomit®) and Stiripentol oral suspension (Diacomit®) in people with Dravet Syndrome and Epilepsy, run by Biocodex at 2 sites in France.
Trial 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 stiripentol (Diacomit®), indicated in Dravet syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dravet Syndrome, Epilepsy, Childhood
- What is being tested?
- Stiripentol capsule (Diacomit®) and Stiripentol oral suspension (Diacomit®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2025to 27 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
3 Chemin d'Armancourt
Compiègne, 60200
EUROFINS OPTIMED, 1 rue des Essarts
Gières, 38610
About this study
Official title: Bioavailability Study of Stiripentol After Single Oral Administration of Two Different Formulations (Capsule and Oral Suspension) in 24 Healthy Subjects
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.
Read more
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.
Read the 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 patients unable to swallow capsules. A previous study in healthy volunteers demonstrated that the capsule and sachet formulations were bioequivalent in terms of AUC but not Cmax. The Cmax of the sachet formulation was approximately 23% higher than that of the capsule, outside the accepted bioequivalence range. As a result, clinical supervision is recommended when switching between capsule and sachet formulations.
According to the European Summary of Product Characteristics (SmPC), stiripentol dosage escalation should be gradual, starting at 20 mg/kg/day and increasing stepwise depending on age. Dravet syndrome typically begins in infancy, and early initiation of antiepileptic treatment is recommended. A new oral suspension formulation (50 mg/mL) has been developed to facilitate flexible dose adjustments and accurate administration in pediatric patients, especially infants, where precise titration is essential.
This clinical study aims to compare the relative bioavailability of the new oral suspension (test formulation) to the capsule (reference formulation) after a single 1,000 mg dose under fed conditions. In addition to pharmacokinetic endpoints, safety, tolerability, and palatability will be assessed in healthy volunteers. The results will provide critical information on whether the new suspension offers a pharmacokinetic profile comparable to the capsule while improving dosing flexibility and patient convenience in clinical practice.
- Being tested
- Stiripentol capsule (Diacomit®), Stiripentol oral suspension (Diacomit®)
- Keywords
- Stiripentol, Diacomit, Oral Suspension, Bioavailability, Pharmacokinetics, Antiepileptic Drug, Crossover Study, Healthy Volunteers, Pediatric Epilepsy, Dravet Syndrome Treatment
- Medical subject headings
- Epilepsies, Myoclonic, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stiripentol capsule (Diacomit®)Drug
Also called Stiripentol 500 mg capsule, Diacomit® capsule
Single oral administration of 1,000 mg stiripentol (2 × 500 mg capsules) at the end of breakfast.
Stiripentol oral suspension (Diacomit®)Drug
Also called Stiripentol 50 mg/mL suspension, Diacomit® oral suspension
Single oral administration of 1,000 mg stiripentol (20 mL oral suspension, 50 mg/mL) at the end of breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A : Stiripentol Capsule then Oral Suspension | Experimental | Subjects randomized to Sequence A will receive a single oral dose of 1,000 mg stiripentol (2 × 500 mg capsules, Diacomit®) at the end of breakfast under fed conditions in Period 1, followed by a single oral dose of 1,000 mg stiripentol (20 mL oral suspension, 50 mg/mL, Diacomit®) in Period 2 after a 7-15 day Receives: Drug: Stiripentol capsule (Diacomit®); Drug: Stiripentol oral suspension (Diacomit®) |
| Sequence B : Stiripentol Oral Suspension then Capsule | Experimental | Subjects randomized to Sequence B will receive a single oral dose of 1,000 mg stiripentol (20 mL oral suspension, 50 mg/mL, Diacomit®) at the end of breakfast under fed conditions in Period 1, followed by a single oral dose of 1,000 mg stiripentol (2 × 500 mg capsules, Diacomit®) in Period 2 after a 7-15 day washout. Receives: Drug: Stiripentol capsule (Diacomit®); Drug: Stiripentol oral suspension (Diacomit®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability of stiripentol oral suspension (50 mg/mL) vs capsule (500 mg) after a single 1,000 mg oral dose with food, assessed by PK parameters Cmax, AUC0-t, and AUC0-∞ using plasma LC-MS.
The relative bioavailability of stiripentol oral suspension (50 mg/mL) versus capsule (500 mg) after a single 1,000 mg oral dose under fed conditions. It will be assessed by calculating geometric mean ratios with 90% confidence intervals for the main pharmacokinetic parameters: maximum observed plasma concentration (Cmax), area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t), and area under the concentration-time curve extrapolated to infinity (AUC0-∞). Plasma concentrations of stiripentol will be measured using validated liquid chromatography-mass spectrometry (LC-MS) methods to ensure accuracy and reliability of the pharmacokinetic evaluation.
Measured: Up to 36 hours post-dose (per period)
Secondary outcomes (12)
Other PK parameters of stiripentol
Time to maximum concentration (tmax)
Measured: Up to 36 hours post-dose (per period).
Safety and tolerability of stiripentol
Number, nature, incidence, seriousness, severity, and resolution of adverse events following single-dose administration.
Measured: From dosing to end of study (~7 weeks per participant).
Palatability of stiripentol oral suspension
Assessed using a self-administered palatability questionnaire completed 20 minutes after administration of the oral suspension
Measured: 20 minutes after administration of the oral suspension
Other PK parameters of stiripentol
Time before start of absorption (tlag)
Measured: Up to 36 hours post-dose (per period)
Other PK parameters of stiripentol
Elimination rate constant (ke)
Measured: Up to 36 hours post-dose (per period)
Other PK parameters of stiripentol
Terminal half-life (t1/2)
Measured: Up to 36 hours post-dose (per period)
PK parameters of stiripentol metabolites (MIa, MIb)
Maximum concentration (Cmax)
Measured: Up to 36 hours post-dose (per period)
PK parameters of stiripentol metabolites (MIa, MIb)
Area under the curve from time 0 (pre-dose) to the last measurable concentration (AUC0-t)
Measured: Up to 36 hours post-dose (per period)
PK parameters of stiripentol metabolites (MIa, MIb)
Area under the curve from time 0 (pre-dose) to infinity (AUC0-∞)
Measured: Up to 36 hours post-dose (per period)
PK parameters of stiripentol metabolites (MIa, MIb)
Time of occurrence of maximum concentration (tmax)
Measured: Up to 36 hours post-dose (per period)
PK parameters of stiripentol metabolites (MIa, MIb)
Elimination rate constant (ke)
Measured: Up to 36 hours post-dose (per period)
PK parameters of stiripentol metabolites (MIa, MIb)
Apparent terminal elimination half-life (t1/2) measured from plasma concentrations using Liquid chromatography-mass spectrometry (LC-MS)
Measured: Up to 36 hours post-dose (per period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Jun 2025
- Primary completion27 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dravet SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single center, two-way, 2 periods, open-label, cross-over, and randomized study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176832
- Sponsor's protocol ID
- STILIQ - STP 218
- Other IDs
- 2024-520103-38-00
- Acronym
- STILIQ
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability Study of Stiripentol After Single Oral Administration of Two Different Formulations (Capsule and Oral Suspension) in 24 Healthy Subjects
- ClinicalTrials.gov ID
- NCT07176832
- Acronym / sponsor ID
- STILIQ / STILIQ - STP 218
- Keywords
- Stiripentol, Diacomit, Oral Suspension, Bioavailability, Pharmacokinetics, Antiepileptic Drug, Crossover Study, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BiocodexIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 patients unable to swallow capsules. A previous study in healthy volunteers demonstrated that the capsule and sachet formulations were bioequivalent in terms of AUC but not Cmax. The Cmax of the sachet formulation was approximately 23% higher than that of the capsule, outside the accepted bioequivalence range. As a result, clinical supervision is recommended when switching between capsule and sachet formulations.
According to the European Summary of Product Characteristics (SmPC), stiripentol dosage escalation should be gradual, starting at 20 mg/kg/day and increasing stepwise depending on age. Dravet syndrome typically begins in infancy, and early initiation of antiepileptic treatment is recommended. A new oral suspension formulation (50 mg/mL) has been developed to facilitate flexible dose adjustments and accurate administration in pediatric patients, especially infants, where precise titration is essential.
This clinical study aims to compare the relative bioavailability of the new oral suspension (test formulation) to the capsule (reference formulation) after a single 1,000 mg dose under fed conditions. In addition to pharmacokinetic endpoints, safety, tolerability, and palatability will be assessed in healthy volunteers. The results will provide critical information on whether the new suspension offers a pharmacokinetic profile comparable to the capsule while improving dosing flexibility and patient convenience in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single center, two-way, 2 periods, open-label, cross-over, and randomized study
| Arm | Type | Receives |
|---|---|---|
| Sequence A : Stiripentol Capsule then Oral Suspension | Experimental | Drug: Stiripentol capsule (Diacomit®), Drug: Stiripentol oral suspension (Diacomit®)Subjects randomized to Sequence A will receive a single oral dose of 1,000 mg stiripentol (2 × 500 mg capsules, Diacomit®) at the end of breakfast under fed conditions in Period 1, followed by a single oral dose of 1,000 mg stiripentol (20 mL oral suspension, 50 mg/mL, Diacomit®) in Period 2 after a 7-15 day |
| Sequence B : Stiripentol Oral Suspension then Capsule | Experimental | Drug: Stiripentol capsule (Diacomit®), Drug: Stiripentol oral suspension (Diacomit®)Subjects randomized to Sequence B will receive a single oral dose of 1,000 mg stiripentol (20 mL oral suspension, 50 mg/mL, Diacomit®) at the end of breakfast under fed conditions in Period 1, followed by a single oral dose of 1,000 mg stiripentol (2 × 500 mg capsules, Diacomit®) in Period 2 after a 7-15 day washout. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stiripentol capsule (Diacomit®)Also: Stiripentol 500 mg capsule, Diacomit® capsuleSingle oral administration of 1,000 mg stiripentol (2 × 500 mg capsules) at the end of breakfast. | Drug | Sequence A : Stiripentol Capsule then Oral Suspension, Sequence B : Stiripentol Oral Suspension then Capsule |
| Stiripentol oral suspension (Diacomit®)Also: Stiripentol 50 mg/mL suspension, Diacomit® oral suspensionSingle oral administration of 1,000 mg stiripentol (20 mL oral suspension, 50 mg/mL) at the end of breakfast. | Drug | Sequence A : Stiripentol Capsule then Oral Suspension, Sequence B : Stiripentol Oral Suspension then Capsule |
Primary outcome
Relative bioavailability of stiripentol oral suspension (50 mg/mL) vs capsule (500 mg) after a single 1,000 mg oral dose with food, assessed by PK parameters Cmax, AUC0-t, and AUC0-∞ using plasma LC-MS.
Time frame: Up to 36 hours post-dose (per period)
The relative bioavailability of stiripentol oral suspension (50 mg/mL) versus capsule (500 mg) after a single 1,000 mg oral dose under fed conditions. It will be assessed by calculating geometric mean ratios with 90% confidence intervals for the main pharmacokinetic parameters: maximum observed plasma concentration (Cmax), area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t), and area under the concentration-time curve extrapolated to infinity (AUC0-∞). Plasma concentrations of stiripentol will be measured using validated liquid chromatography-mass spectrometry (LC-MS) methods to ensure accuracy and reliability of the pharmacokinetic evaluation.
12 secondary outcomes
Other PK parameters of stiripentol
Time frame: Up to 36 hours post-dose (per period).
Safety and tolerability of stiripentol
Time frame: From dosing to end of study (~7 weeks per participant).
Palatability of stiripentol oral suspension
Time frame: 20 minutes after administration of the oral suspension
Other PK parameters of stiripentol
Time frame: Up to 36 hours post-dose (per period)
Other PK parameters of stiripentol
Time frame: Up to 36 hours post-dose (per period)
Other PK parameters of stiripentol
Time frame: Up to 36 hours post-dose (per period)
PK parameters of stiripentol metabolites (MIa, MIb)
Time frame: Up to 36 hours post-dose (per period)
PK parameters of stiripentol metabolites (MIa, MIb)
Time frame: Up to 36 hours post-dose (per period)
PK parameters of stiripentol metabolites (MIa, MIb)
Time frame: Up to 36 hours post-dose (per period)
PK parameters of stiripentol metabolites (MIa, MIb)
Time frame: Up to 36 hours post-dose (per period)
PK parameters of stiripentol metabolites (MIa, MIb)
Time frame: Up to 36 hours post-dose (per period)
PK parameters of stiripentol metabolites (MIa, MIb)
Time frame: Up to 36 hours post-dose (per period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stiripentol capsule (Diacomit®) and Stiripentol oral suspension (Diacomit®) in people with Dravet Syndrome and Epilepsy, run by Biocodex at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative bioavailability of stiripentol oral suspension (50 mg/mL) vs capsule (500 mg) after a single 1,000 mg oral dose with food, assessed by PK parameters Cmax, AUC0-t, and AUC0-∞ using plasma LC-MS. (time frame: Up to 36 hours post-dose (per period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.