Healthy VolunteersPhase 1NCT03866928
Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers
A Phase 1 study testing Stiripentol in people with Healthy Volunteers, run by Biocodex at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Stiripentol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Feb 2019to 5 Apr 2019
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be required to satisfy the following criteria:
- Healthy male subject, aged between 18 and 45 years inclusive.
- Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Body mass index (BMI) between 18 and 30 kg/m² inclusive.
- Normal blood pressure (BP) and heart rate (HR) at the screening visit after 5 min in supine position:
- 90 mmHg ≤ Systolic Blood Pressure (SBP) ≤ 145 mmHg,
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- 45 mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg,
- 40 bpm ≤ HR ≤ 90 bpm,
- Or considered not clinically significant (NCS) by the Investigator.
- Normal electrocardiogram (ECG) recording on a 10 min resting 12-lead ECG at the screening visit:
- 120 ≤ interval between P and R waves (PR) < 210 ms,
- Interval between Q and S waves (QRS) < 120 ms,
- Fridericia corrected interval between Q and T waves (QTcF) ≤ 450 ms,
- No sign of any trouble of sinusal automatism,
- Or considered NCS by the Investigator.
- Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator.
- Normal dietary habits.
- Has given written informed consent.
Who cannot join
- All the subjects included in the study must not meet any of the following non-inclusion criteria.
- Unsuitable veins for repeated venipuncture.
- Any relevant history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, infectious disease or psychiatric disorders,
- Evidence of any clinically significant acute or chronic disease,
- Surgery or blood donation (including in the frame of a clinical trial) within 2 months before administration,
- Presence or relevant history of drug hypersensitivity, asthma or allergic disease diagnosed and treated by a physician,
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- Known hypersensitivity to any of the test materials or related compounds,
- Inability to abstain from intensive muscular effort,
- Inability or difficulty swallowing whole capsules
- No possibility of contact in case of emergency,
- Any drug intake (except paracetamol) including over the counter (OTC) medications and herbal products that could affect the outcome of the study, within 2 weeks prior to the first drug administration or less than 5 times the t1/2 of that drug, whichever is longer,
- Who receive carbamazepine, phenytoin or phenobarbital known to affect hepatic metabolism within 1 month prior to the first dose administration,
- Who receive any drug known to interfere with CYP enzymes within 1 month prior to the first dose administration,
- History or presence of drug or alcohol abuse (alcohol consumption > 4 glasses per day (1 glass is approximately equivalent to: beer [354 mL], wine [118 mL], or distilled spirits [29.5 mL]) per day)),
- Excessive consumption of beverages with xanthine bases (> 5 cups or glasses / day),
- Current use of nicotine containing products, i.e., more than 5 cigarettes or equivalent/day or the inability to stop using nicotine containing products during confinement in the clinical center,
- Intake of any food or any beverage containing grapefruit or grapefruit juice within one week prior to the first dosing and the inability to stop such intake during the study,
- Positive Hepatitis B surface antigen (HBsAg) or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests,
- Positive results of screening for drugs of abuse,
- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development,
- Exclusion period of a previous study,
- Administrative or legal supervision.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Stiripentol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StiripentolDrug
1500 mg of stiripentol b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Stiripentol | Experimental | Not described Receives: Drug: Stiripentol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration [Cmax]
To determine Cmax of stiripentol and its metabolites (if any are detected) in plasma
Measured: On Days 1 and 15
Area Under the Curve [AUC]
To determine AUC of stiripentol and its metabolites (if any are detected) in plasma
Measured: On Days 1 and 15
Time that a drug is present at the maximum concentration [Tmax]
To determine Tmax of stiripentol and its metabolites (if any are detected) in plasma
Measured: On Days 1 and 15
The minimum concentration [Cmin]
To determine Cmin of stiripentol and its metabolites (if any are detected) in plasma
Measured: From Day 2 to Day 15
Amount of drug excreted in urine [Ae]
To determine Ae of stiripentol and its metabolites (if any are detected) in urine
Measured: From Day 2 to Day 15
Fraction of the dose excreted in urine [fe]
To determine fe of stiripentol and its metabolites (if any are detected) in urine
Measured: From Day 2 to Day 15
Secondary outcomes (1)
Treatment-related adverse events [TRAEs]
To assess the safety and tolerability of stiripentol and its metabolites (if any are detected) after multiple oral doses of 1500 mg b.i.d in healthy male volunteers
Measured: From start of participation of the subject until 4 weeks after the last administration of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start12 Feb 2019
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866928
- Sponsor's protocol ID
- STP199
- Status last verified
- Dec 2019
- First submitted
- 5 Mar 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03866928
- Acronym / sponsor ID
- STP199
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BiocodexIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 7 Mar 2019 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stiripentol | Experimental | Drug: Stiripentol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Healthy male subject, aged between 18 and 45 years inclusive.
- Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Body mass index (BMI) between 18 and 30 kg/m² inclusive.
- Normal blood pressure (BP) and heart rate (HR) at the screening visit after 5 min in supine position:
- Normal electrocardiogram (ECG) recording on a 10 min resting 12-lead ECG at the screening visit:
Key exclusion criteria (22 listed)
- All the subjects included in the study must not meet any of the following non-inclusion criteria.
- Unsuitable veins for repeated venipuncture.
- Any relevant history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, infectious disease or psychiatric disorders,
- Evidence of any clinically significant acute or chronic disease,
- Surgery or blood donation (including in the frame of a clinical trial) within 2 months before administration,
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 |
|---|---|---|
| Stiripentol1500 mg of stiripentol b.i.d. | Drug | Stiripentol |
Primary outcome
Maximum Plasma Concentration [Cmax]
Time frame: On Days 1 and 15
To determine Cmax of stiripentol and its metabolites (if any are detected) in plasma
Area Under the Curve [AUC]
Time frame: On Days 1 and 15
To determine AUC of stiripentol and its metabolites (if any are detected) in plasma
Time that a drug is present at the maximum concentration [Tmax]
Time frame: On Days 1 and 15
To determine Tmax of stiripentol and its metabolites (if any are detected) in plasma
The minimum concentration [Cmin]
Time frame: From Day 2 to Day 15
To determine Cmin of stiripentol and its metabolites (if any are detected) in plasma
Amount of drug excreted in urine [Ae]
Time frame: From Day 2 to Day 15
To determine Ae of stiripentol and its metabolites (if any are detected) in urine
Fraction of the dose excreted in urine [fe]
Time frame: From Day 2 to Day 15
To determine fe of stiripentol and its metabolites (if any are detected) in urine
1 secondary outcome
Treatment-related adverse events [TRAEs]
Time frame: From start of participation of the subject until 4 weeks after the last administration of the study drug
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 20 Dec 2019.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
1 site 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 in people with Healthy Volunteers, run by Biocodex at 1 site in Belgium.
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 18 inclusion and 22 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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Maximum Plasma Concentration [Cmax] (time frame: On Days 1 and 15). The study lists 6 primary outcomes in all. 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 20 Dec 2019.