Chronic Renal InsufficiencyPhase 1STP237NCT05735951
Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function
A Phase 1 study testing STIRIPENTOL oral administration in people with Chronic Renal Insufficiency, run by Biocodex at 1 site in Bulgaria.
Trial summary
The purpose of this study is to determine whether the pharmacokinetics (PK) of stiripentol and of its relevant metabolites would be altered in subjects with renal impairment compared with normal controls in order to assess the need of dose adjustment in the renal impaired population. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Insufficiency
- What is being tested?
- STIRIPENTOL oral administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBulgaria
- Study dates
- 24 Jul 2023to 30 Nov 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects/patients will be required to satisfy all the following inclusion criteria to be included in the study:
- Male or female subjects, aged 18 to 80 years inclusive,
- Females participating in this study must be of non-childbearing potential or using highly effective contraception for the full duration of the study and for 1 month after the end of treatment,
- Negative serum pregnancy test at screening and urinary pregnancy test at Day -1 (if applicable),
- A negative antigen test for Coronavirus Disease 19 (COVID 19),
- Normal hepatic function (AST < 3xULN (Upper limit normal), ALT (Alanine aminotransferase); <1.5 ULN; bilirubin),
Show all 47Show fewer
- Non-smoker subject or smoker of not more than 5 cigarettes a day,
- Signing a written informed consent in their native language prior to selection,
- Additional inclusion criteria for renally impaired patients
- Patients with renal impairment will be required to satisfy all the following inclusion criteria to be included in the study:
- Documented renal impairment indicated by reduced RF at least 12 months of screening or longer,
- Stable renal function (eGFR) as evidenced by ≤ 30% difference in two evaluations of Renal function (RF) on two separate occasions separated by at least 28 days with one measurement being the value at screening,
- Renal impairment within the following ranges (using the Modification of Diet in Renal Disease-4 (MDRD4) equation) at screening:
- mild renal impairment with eGFR ≥ 60 to < 90 mL/min/1.73 m²,
- moderate renal impairment with eGFR ≥ 30 to < 60 mL/min/1.73 m²,
- severe renal impairment with eGFR < 30 mL/min/1.73 m² and not on dialysis,
- Supine blood pressure (BP) ≤ 180/104 mmHg,
- Heart rate between 50-100 bpm, DBP between 40-100 mmHg and SBP between 90-170 mmHg extremities excluded,
- Normal or non-clinically significant finding in ECG recording on a 10 min resting 12-lead ECG at the screening visit (left ventricular hypertrophy related with hypertension, will be allowed):
- HR [50-100 bpm],
- 110 ms ≤ interval between P and R waves (PR) < 220 ms,
- Interval between Q and S waves (QRS) < 120 ms,
- Fridericia corrected interval between Q and T waves (QTcF) ≤ 450 ms, 470 ms for female,
- No sign of any trouble of sinusal automatism,
- Or considered NCS by the Investigator,
- Body Mass Index (BMI) between 18 and 35 kg/m² inclusive.
- Additional inclusion criteria for matching controls
- Matching controls will be required to satisfy all the following inclusion criteria to be included in the study:
- Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination),
- eGFR ≥ 90 mL/min/1.73 m²,
- No proteinuria (i.e., no trace or positive dipstick results),
- BMI between 18 and 35 kg/m2 inclusive and body weight,
- Normal BP and heart rate (HR) at the screening visit after 5 min in supine position:
- 90 mmHg ≤ Systolic Blood Pressure (SBP) ≤ 145 mmHg, for elderly subjects (> 60 years) an upper limit of 150 mmHg,
- 45 mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg, for elderly subjects (> 60 years) an upper limit of 95 mmHg,
- 50 bpm ≤ HR ≤ 100 bpm,
- Or value outside these limits but considered not clinically significant (NCS) by the Investigator,
- Normal ECG recording on a 10 min resting 12-lead ECG at the screening visit:
- HR [50-100 bpm],
- 110 ≤ interval between P and R waves (PR) < 220 ms,
- Interval between Q and S waves (QRS) < 120 ms,
- Fridericia corrected interval between Q and T waves (QTcF) ≤ 450 ms, 470 ms for female,
- No sign of any trouble of sinusal automatism,
- Or considered NCS by the Investigator,
- Laboratory parameters within the normal range or considered NCS by the Investigator 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,
- Matched to at least 1 renally impaired patient by ethnic group, sex, age (+/- 10 years) and BMI (+/-20%).
Who cannot join
- Non-inclusion criteria for all subjects
- All the subjects/patients included in the study must not meet any of the following non-inclusion criteria:
- Unsuitable veins for repeated venipuncture,
- Positive Hepatitis B surface (HBsAg) antigen or positive Hepatitis C Virus (HCV), or positive results for Human Immunodeficiency Virus (HIV)-1 or 2 tests,
- History or presence of drug or alcohol abuse (alcohol consumption >40 grams/day),
- Subject/Patient 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,
Show all 35Show fewer
- Subject/Patient who cannot be contacted in case of emergency,
- History or presence of allergy or unusual reactions to some drugs or anesthetics or known hypersensitivity to the investigation product or its excipients (including lactose intolerance), test material or related compound,
- Who receive a medication known to affect both cyochromes (CYP) CYP1A2, CYP3A4, and CYP2C19, such as rifampin, within 1 month prior to the first dose administration. Concomitant use of medications known to strongly affect either CYP1A2, CYP3A4, or CYP2C19, such as phenytoin, phenobarbital or carbamazepine, should be avoided within 1 month prior to the first dose administration.
- Subject/Patient who is in the exclusion period of a previous study,
- Administrative or legal supervision,
- Blood donation (including in the frame of a clinical trial) within 2 months before administration,
- Subject/Patient who is pregnant, in labour or breastfeeding. Subject/Patient should not be enrolled if she plans to become pregnant during the time of study participation,
- Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day),
- Positive COVID 19 antigen test, or COVID-19 vaccination within 14 days of the first dosing.
- The consumption of grapefruit/grapefruits production, Sevilla oranges, or any poppy seeds, are not allowed from 7 days prior to the first study drug administration,
- Evidence or history of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, metabolic, systemic, infectious, or allergic disease (including drug hypersensitivity or allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). However, investigator will have the possibility to judge whether a subject could be included with uncontrolled disease (e.g. in case of non-treated dyslipidemia),
- General anesthesia within 3 months before administration,
- Major surgery within 28 days prior to inclusion or major surgery planned during the next 6 months,
- Inability to abstain from intensive muscular effort,
- Inability or difficulty swallowing whole capsules,
- Additional non-inclusion criteria for renal impaired patients
- Patients with renal impairment included in the study must not meet any of the following non-inclusion criteria:
- History of renal transplant,
- The patient has evidence of an unstable clinically important medical condition other than impaired renal function,
- The patient has an acute exacerbation or unstable renal function, as indicated by worsening of clinical and/or laboratory signs of renal impairment, within the 4 weeks before study drug administration,
- Patients undergoing any method of dialysis or hemofiltration,
- Disorders or surgery of the gastrointestinal tract which may interfere with drug absorption or may otherwise influence the pharmacokinetics (PK) of the investigational medicinal product (IMP) (e.g., inflammatory bowel disease, resections of the small or large intestine, etc.),
- History of febrile illness within 5 days prior to dosing,
- Evidence of clinically significant liver disease or liver damage (e.g., hepatitis B or C, autoimmune hepatitis, primary biliary cirrhosis, non-alcoholic fatty liver disease, elevated aspartate aminotransferase (AST) or ALT that is considered clinically significant by the Investigator, etc.),
- Patient with a change in current treatments during the last month or receiving any drug known to be potent CYP1A2, CYP3A4 and CYP2C19 inducers, such as rifampin.
- Additional non-inclusion criteria for matching controls Matching controls with normal renal function included in the study must not meet any of the following noninclusion criteria:
- Any history or presence of renal disease,
- Frequent headaches (> twice a month) and / or migraines, recurrent nausea and / or vomiting,
- Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP (≥20 mmHg) or DBP (≥10 mmHg) within 2 min when changing from the supine to the standing position, Intake of any medication (except paracetamol, hormonal contraceptives and hormone replacement therapy for post-menopausal women), including over the counter (OTC) medications and herbal products, that could affect the outcome of the study is prohibited within 2 weeks prior to the first drug administration or less than 5 times the t1/2 of that drug, whichever is the longer, or participant receiving any drug known to interfere with CYP enzymes within 1 month prior to the first dose administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Multiple Oral Administration of Stiripentol 1000 mg in Renal Impaired Patients and Matching Controls With Normal Renal Function
The purpose of this study is to determine whether the pharmacokinetics (PK) of stiripentol and of its relevant metabolites would be altered in subjects with renal impairment compared with normal controls in order to assess the need of dose adjustment in the renal impaired population. This study will include subjects with mild, moderate and severe renal impairment.
Read the detailed description
The pharmacokinetic studies conducted with stiripentol in humans evidenced that at steady state after multiple administration, up to 54.1%. of the stiripentol dose was excreted unchanged in hydrolyzed urine over the 24 h interval. Stiripentol is extensively metabolized by the liver; around 20 metabolites have been detected in urine, but the fraction of dose excreted as unchanged stiripentol is much less than one percent. At steady state, stiripentol and its metabolites in urine accounted collectively for 90% of the oral dose.
The risk of a clinically relevant increase in exposure in renal impairment is expected to be largest for drugs that are primarily renally eliminated, according to the European Medicines Agency (EMA) guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function and the draft Food and Drug Administration's (FDA) guidance for industry "Pharmacokinetics in Patients with Impaired Renal Function - Study Design, Data Analysis, and Impact on Dosing and Labeling". But since the literature shows that impaired renal function can alter some drug metabolism and transport pathways in the liver and gut a dedicated renal impairment study with a full pharmacokinetics (PK) design is recommended.
Therefore, the purpose of this study is to determine whether the pharmacokinetics (PK) of stiripentol and of its relevant metabolites would be altered in subjects with renal impairment compared with normal controls in order to assess the need of dose adjustment in the renal impaired population. This study will include subjects with mild, moderate and severe renal impairment.
Data from subjects with renal impairment will be compared to matched controls with normal renal function. Both groups should be similar with respect to sex, age, BMI and ethnicity. This approach is consistent with recommendations of the EMA guideline and FDA guidance for pharmacokinetics (PK) in patients with renal function as the control group in this study should be representative of the typical patient population for the drug under study, considering the patients' renal function and other factors known to affect the drug's pharmacokinetics (PK).
Plasma protein binding is often altered in patients with impaired renal function. Stiripentol is strongly bound (>99%) to plasma proteins. Therefore, the EMA guideline and FDA guidance recommend the measurement of unbound drug concentrations. Therefore, the fraction of unbound stiripentol will be determined using two samples taken pre-dose and 3 h post-dose on Day 15 from each subject on-study.
- Conditions
- Chronic Renal Insufficiency
- Being tested
- STIRIPENTOL oral administration
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STIRIPENTOL oral administrationDrug
Also called Multiple oral administration of stiripentol 1000 mg bis in die (BID)
Oral administration of:
- Days 1 and 2: 1000 mg of stiripentol (single dose at the end of breakfast),
- Day 3 to Day 14: 1000 mg of stiripentol bis in die (BID) (approximately 12 hours apart, at the end of breakfast and at the end of dinner),
- Day 15: 1000 mg of stiripentol (single dose at the end of breakfast).
| Study group | Role | What they receive |
|---|---|---|
| Mild renally impaired patients | Experimental | Mild renally impaired patients Receives: Drug: STIRIPENTOL oral administration |
| Moderate renally impaired patients | Experimental | Moderate renally impaired patients Receives: Drug: STIRIPENTOL oral administration |
| Severe renally impaired patients | Experimental | Severe renally impaired patients Receives: Drug: STIRIPENTOL oral administration |
| Matching controls | Experimental | Matching volunteer without renal impairement Receives: Drug: STIRIPENTOL oral administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve
Area under the plasma concentration versus time curve: AUC0-12 (corresponding to AUC0-tau), in order to assess the need of dose adjustment in the renal impaired population.
Measured: Steady state at Day15
Peak Plasma Concentration
Peak Plasma Concentration: Cmax in order to assess the need of dose adjustment in the renal impaired population.
Measured: Steady state at Day15
Secondary outcomes (25)
Peak Plasma Concentration, for stiripentol in plasma
Peak Plasma Concentration : Cmax on Day 1
Measured: Day 1 and Day 15 when applicable
The area under the concentration-time curve from time zero (pre-dose) to 12 h post-dose, for stiripentol in plasma
The area under the concentration-time curve from time zero (pre-dose) to 12 h post-dose: AUC0-12 corresponds to AUC0-tau on Day 15): AUC0-12 on Day 1
Measured: Day 1 and Day 15 when applicable
The time at which Cmax is apparent, for stiripentol in plasma
The time at which Cmax is apparent: tmax
Measured: Day 1 and Day 15 when applicable
The area under the concentration-time curve from time zero (pre-dose) to 24 h post-dose, for stiripentol in plasma
The area under the concentration-time curve from time zero (pre-dose) to 24 h post-dose: AUC0-24,
Measured: Day 1 and Day 15 when applicable
The area under the concentration-time from time zero (pre-dose) to the time of last quantifiable concentration, for stiripentol in plasma
The area under the concentration-time from time zero (pre-dose) to the time of last quantifiable concentration: AUC0-t
Measured: Day 1 and Day 15 when applicable
The apparent terminal elimination half-life, for stiripentol in plasma
The apparent terminal elimination half-life t1/2
Measured: Day 1 and Day 15 when applicable
Apparent total clearance at steady-state, for stiripentol in plasma
Apparent total clearance at steady-state: CLss/F
Measured: Day 1 and Day 15 when applicable
Fraction unbound (stiripentol) in plasma defined as unbound concentration/total concentration (on Day 15 only), for stiripentol in plasma
Fraction unbound (stiripentol) in plasma defined as unbound concentration/total concentration (on Day 15 only) : Fu
Measured: Day 1 and Day 15 when applicable
Pre-morning dose concentration, for stiripentol in plasma
Pre-morning dose concentration : Cmin
Measured: Day 1 and Day 15 when applicable
Accumulation ratio evaluated, for stiripentol in plasma
Accumulation ratio evaluated: Racc
Measured: Day 1 and Day 15 when applicable
Total amount excreted over the time interval between 0 and 12 h, for stiripentol in urine
Total amount excreted over the time interval between 0 and 12 h : Ae0-12
Measured: Day 1 and Day 15 when applicable
Total amount excreted over the total time interval of urine collection i.e. ]0 - 24] h, for stiripentol in urine
Total amount excreted over the total time interval of urine collection i.e. ]0 - 24] h : Ae0-24
Measured: Day 1 and Day 15 when applicable
The fraction of the dose excreted in urine over the total time interval of urine collection i.e. ]0 - 24] h, for stiripentol in urine
The fraction of the dose excreted in urine over the total time interval of urine collection i.e. ]0 - 24] h : fe0-24
Measured: Day 1 and Day 15 when applicable
The renal clearance, for stiripentol in urine
The renal clearance : CLr
Measured: Day 1 and Day 15 when applicable
Peak Plasma Concentration, for stiripentol relevant metabolites in plasma
Peak Plasma Concentration : Cmax
Measured: Day 1 and Day 15 when applicable
The time at which Cmax is apparent, for stiripentol relevant metabolites in plasma
Peak Plasma Concentration : Cmax
Measured: Day 1 and Day 15 when applicable
The area under the concentration-time curve from time zero (pre-dose) to 12 h post-dose: AUC0-12 corresponds to AUC0-tau on Day 15), for stiripentol relevant metabolites in plasma
The area under the concentration-time curve from time zero (pre-dose) to 12 h post-dose: AUC0-12 corresponds to AUC0-tau on Day 15) : AUC0-12,
Measured: Day 1 and Day 15 when applicable
The area under the concentration-time curve from time zero (pre-dose) to 24 h post-dose, for stiripentol relevant metabolites in plasma
The area under the concentration-time curve from time zero (pre-dose) to 24 h post-dose: AUC0-24,
Measured: Day 1 and Day 15 when applicable
The area under the concentration-time from time zero (pre-dose) to the time of last quantifiable concentration, for stiripentol relevant metabolites in plasma
The area under the concentration-time from time zero (pre-dose) to the time of last quantifiable concentration: AUC0-t,
Measured: Day 1 and Day 15 when applicable
The apparent terminal elimination half-life, for stiripentol relevant metabolites in plasma
The apparent terminal elimination half-life : t1/2,
Measured: Day 1 and Day 15 when applicable
Pre-morning dose concentration, for stiripentol relevant metabolites in plasma
Pre-morning dose concentration : Cmin.
Measured: Day 1 and Day 15 when applicable
Total amount excreted over the time interval between 0 and 12 h, for stiripentol relevant metabolites in urine
Total amount excreted over the time interval between 0 and 12 h : Ae0-12
Measured: Day 1 and Day 15 when applicable
Total amount excreted over the total time interval of urine collection i.e. ]0 - 24] h, for stiripentol relevant metabolites in urine
Total amount excreted over the total time interval of urine collection i.e. ]0 - 24] h : Ae0-24
Measured: Day 1 and Day 15 when applicable
The fraction of the dose excreted in urine over the total time interval of urine collection i.e. ]0 - 24] h, for stiripentol relevant metabolites in urine
The fraction of the dose excreted in urine over the total time interval of urine collection i.e. ]0 - 24] h : fe0-24
Measured: Day 1 and Day 15 when applicable
The renal clearance, for stiripentol relevant metabolites in urine
The renal clearance : CLr
Measured: Day 1 and Day 15 when applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start24 Jul 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal InsufficiencyStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diyan Genov, MD, Principal investigator, Comac Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735951
- Sponsor's protocol ID
- JADE
- Acronym
- STP237
- Status last verified
- Aug 2025
- First submitted
- 30 Jan 2023
- Last updated
- 5 Sep 2025
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Multiple Oral Administration of Stiripentol 1000 mg in Renal Impaired Patients and Matching Controls With Normal Renal Function
- ClinicalTrials.gov ID
- NCT05735951
- Acronym / sponsor ID
- STP237 / JADE
- Conditions
- Chronic Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- BiocodexIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 21 Feb 2023 (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.
The purpose of this study is to determine whether the pharmacokinetics (PK) of stiripentol and of its relevant metabolites would be altered in subjects with renal impairment compared with normal controls in order to assess the need of dose adjustment in the renal impaired population. This study will include subjects with mild, moderate and severe renal impairment.
Detailed description
The pharmacokinetic studies conducted with stiripentol in humans evidenced that at steady state after multiple administration, up to 54.1%. of the stiripentol dose was excreted unchanged in hydrolyzed urine over the 24 h interval. Stiripentol is extensively metabolized by the liver; around 20 metabolites have been detected in urine, but the fraction of dose excreted as unchanged stiripentol is much less than one percent. At steady state, stiripentol and its metabolites in urine accounted collectively for 90% of the oral dose.
The risk of a clinically relevant increase in exposure in renal impairment is expected to be largest for drugs that are primarily renally eliminated, according to the European Medicines Agency (EMA) guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function and the draft Food and Drug Administration's (FDA) guidance for industry "Pharmacokinetics in Patients with Impaired Renal Function - Study Design, Data Analysis, and Impact on Dosing and Labeling". But since the literature shows that impaired renal function can alter some drug metabolism and transport pathways in the liver and gut a dedicated renal impairment study with a full pharmacokinetics (PK) design is recommended.
Therefore, the purpose of this study is to determine whether the pharmacokinetics (PK) of stiripentol and of its relevant metabolites would be altered in subjects with renal impairment compared with normal controls in order to assess the need of dose adjustment in the renal impaired population. This study will include subjects with mild, moderate and severe renal impairment.
Data from subjects with renal impairment will be compared to matched controls with normal renal function. Both groups should be similar with respect to sex, age, BMI and ethnicity. This approach is consistent with recommendations of the EMA guideline and FDA guidance for pharmacokinetics (PK) in patients with renal function as the control group in this study should be representative of the typical patient population for the drug under study, considering the patients' renal function and other factors known to affect the drug's pharmacokinetics (PK).
Plasma protein binding is often altered in patients with impaired renal function. Stiripentol is strongly bound (>99%) to plasma proteins. Therefore, the EMA guideline and FDA guidance recommend the measurement of unbound drug concentrations. Therefore, the fraction of unbound stiripentol will be determined using two samples taken pre-dose and 3 h post-dose on Day 15 from each subject on-study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild renally impaired patients | Experimental | Drug: STIRIPENTOL oral administrationMild renally impaired patients |
| Moderate renally impaired patients | Experimental | Drug: STIRIPENTOL oral administrationModerate renally impaired patients |
| Severe renally impaired patients | Experimental | Drug: STIRIPENTOL oral administrationSevere renally impaired patients |
| Matching controls | Experimental | Drug: STIRIPENTOL oral administrationMatching volunteer without renal impairement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (47 listed)
- Subjects/patients will be required to satisfy all the following inclusion criteria to be included in the study:
- Male or female subjects, aged 18 to 80 years inclusive,
- Females participating in this study must be of non-childbearing potential or using highly effective contraception for the full duration of the study and for 1 month after the end of treatment,
- Negative serum pregnancy test at screening and urinary pregnancy test at Day -1 (if applicable),
- A negative antigen test for Coronavirus Disease 19 (COVID 19),
Key exclusion criteria (35 listed)
- Non-inclusion criteria for all subjects
- All the subjects/patients included in the study must not meet any of the following non-inclusion criteria:
- Unsuitable veins for repeated venipuncture,
- Positive Hepatitis B surface (HBsAg) antigen or positive Hepatitis C Virus (HCV), or positive results for Human Immunodeficiency Virus (HIV)-1 or 2 tests,
- History or presence of drug or alcohol abuse (alcohol consumption >40 grams/day),
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 oral administrationAlso: Multiple oral administration of stiripentol 1000 mg bis in die (BID)Oral administration of: * Days 1 and 2: 1000 mg of stiripentol (single dose at the end of breakfast), * Day 3 to Day 14: 1000 mg of stiripentol bis in die (BID) (approximately 12 hours apart, at the end of breakfast and at the end of dinner), * Day 15: 1000 mg of stiripentol (single dose at the end of breakfast). | Drug | Matching controls, Mild renally impaired patients, Moderate renally impaired patients, Severe renally impaired patients |
Primary outcome
Area under the plasma concentration versus time curve
Time frame: Steady state at Day15
Area under the plasma concentration versus time curve: AUC0-12 (corresponding to AUC0-tau), in order to assess the need of dose adjustment in the renal impaired population.
Peak Plasma Concentration
Time frame: Steady state at Day15
Peak Plasma Concentration: Cmax in order to assess the need of dose adjustment in the renal impaired population.
25 secondary outcomes
Peak Plasma Concentration, for stiripentol in plasma
Time frame: Day 1 and Day 15 when applicable
The area under the concentration-time curve from time zero (pre-dose) to 12 h post-dose, for stiripentol in plasma
Time frame: Day 1 and Day 15 when applicable
The time at which Cmax is apparent, for stiripentol in plasma
Time frame: Day 1 and Day 15 when applicable
The area under the concentration-time curve from time zero (pre-dose) to 24 h post-dose, for stiripentol in plasma
Time frame: Day 1 and Day 15 when applicable
The area under the concentration-time from time zero (pre-dose) to the time of last quantifiable concentration, for stiripentol in plasma
Time frame: Day 1 and Day 15 when applicable
The apparent terminal elimination half-life, for stiripentol in plasma
Time frame: Day 1 and Day 15 when applicable
Apparent total clearance at steady-state, for stiripentol in plasma
Time frame: Day 1 and Day 15 when applicable
Fraction unbound (stiripentol) in plasma defined as unbound concentration/total concentration (on Day 15 only), for stiripentol in plasma
Time frame: Day 1 and Day 15 when applicable
Pre-morning dose concentration, for stiripentol in plasma
Time frame: Day 1 and Day 15 when applicable
Accumulation ratio evaluated, for stiripentol in plasma
Time frame: Day 1 and Day 15 when applicable
Total amount excreted over the time interval between 0 and 12 h, for stiripentol in urine
Time frame: Day 1 and Day 15 when applicable
Total amount excreted over the total time interval of urine collection i.e. ]0 - 24] h, for stiripentol in urine
Time frame: Day 1 and Day 15 when applicable
The fraction of the dose excreted in urine over the total time interval of urine collection i.e. ]0 - 24] h, for stiripentol in urine
Time frame: Day 1 and Day 15 when applicable
The renal clearance, for stiripentol in urine
Time frame: Day 1 and Day 15 when applicable
Peak Plasma Concentration, for stiripentol relevant metabolites in plasma
Time frame: Day 1 and Day 15 when applicable
The time at which Cmax is apparent, for stiripentol relevant metabolites in plasma
Time frame: Day 1 and Day 15 when applicable
The area under the concentration-time curve from time zero (pre-dose) to 12 h post-dose: AUC0-12 corresponds to AUC0-tau on Day 15), for stiripentol relevant metabolites in plasma
Time frame: Day 1 and Day 15 when applicable
The area under the concentration-time curve from time zero (pre-dose) to 24 h post-dose, for stiripentol relevant metabolites in plasma
Time frame: Day 1 and Day 15 when applicable
The area under the concentration-time from time zero (pre-dose) to the time of last quantifiable concentration, for stiripentol relevant metabolites in plasma
Time frame: Day 1 and Day 15 when applicable
The apparent terminal elimination half-life, for stiripentol relevant metabolites in plasma
Time frame: Day 1 and Day 15 when applicable
Pre-morning dose concentration, for stiripentol relevant metabolites in plasma
Time frame: Day 1 and Day 15 when applicable
Total amount excreted over the time interval between 0 and 12 h, for stiripentol relevant metabolites in urine
Time frame: Day 1 and Day 15 when applicable
Total amount excreted over the total time interval of urine collection i.e. ]0 - 24] h, for stiripentol relevant metabolites in urine
Time frame: Day 1 and Day 15 when applicable
The fraction of the dose excreted in urine over the total time interval of urine collection i.e. ]0 - 24] h, for stiripentol relevant metabolites in urine
Time frame: Day 1 and Day 15 when applicable
The renal clearance, for stiripentol relevant metabolites in urine
Time frame: Day 1 and Day 15 when applicable
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 5 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Chronic Renal Insufficiency
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Diyan Genov, MD principal investigator
Comac Medical
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 oral administration in people with Chronic Renal Insufficiency, run by Biocodex at 1 site in Bulgaria.
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 47 inclusion and 35 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 5 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 1 site in Bulgaria. 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?
Area under the plasma concentration versus time curve (time frame: Steady state at Day15). The study lists 2 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 5 Sep 2025.