- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03866928
Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers
December 19, 2019 updated by: Biocodex
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 Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Liège, Belgium
- ATC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
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,
- 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.
Exclusion Criteria:
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,
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Stiripentol
|
1500 mg of stiripentol b.i.d.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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On Days 1 and 15
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Area Under the Curve [AUC]
Time Frame: On Days 1 and 15
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To determine AUC of stiripentol and its metabolites (if any are detected) in plasma
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On Days 1 and 15
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Time that a drug is present at the maximum concentration [Tmax]
Time Frame: On Days 1 and 15
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To determine Tmax of stiripentol and its metabolites (if any are detected) in plasma
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On Days 1 and 15
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The minimum concentration [Cmin]
Time Frame: From Day 2 to Day 15
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To determine Cmin of stiripentol and its metabolites (if any are detected) in plasma
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From Day 2 to Day 15
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Amount of drug excreted in urine [Ae]
Time Frame: From Day 2 to Day 15
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To determine Ae of stiripentol and its metabolites (if any are detected) in urine
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From Day 2 to Day 15
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Fraction of the dose excreted in urine [fe]
Time Frame: From Day 2 to Day 15
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To determine fe of stiripentol and its metabolites (if any are detected) in urine
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From Day 2 to Day 15
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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From start of participation of the subject until 4 weeks after the last administration of the study drug
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 12, 2019
Primary Completion (ACTUAL)
April 5, 2019
Study Completion (ACTUAL)
April 5, 2019
Study Registration Dates
First Submitted
March 5, 2019
First Submitted That Met QC Criteria
March 6, 2019
First Posted (ACTUAL)
March 7, 2019
Study Record Updates
Last Update Posted (ACTUAL)
December 20, 2019
Last Update Submitted That Met QC Criteria
December 19, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STP199
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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