NCT03866928已完成1 期
Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biocodex
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The minimum concentration [Cmin]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Stiripentol
Experimental
干预措施: Stiripentol (Drug)
结局指标
主要结局
The minimum concentration [Cmin]
时间窗: From Day 2 to Day 15
To determine Cmin of stiripentol and its metabolites (if any are detected) in plasma
Maximum Plasma Concentration [Cmax]
时间窗: On Days 1 and 15
To determine Cmax of stiripentol and its metabolites (if any are detected) in plasma
Area Under the Curve [AUC]
时间窗: 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]
时间窗: On Days 1 and 15
To determine Tmax of stiripentol and its metabolites (if any are detected) in plasma
Amount of drug excreted in urine [Ae]
时间窗: 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]
时间窗: From Day 2 to Day 15
To determine fe of stiripentol and its metabolites (if any are detected) in urine
次要结局
- Treatment-related adverse events [TRAEs](From start of participation of the subject until 4 weeks after the last administration of the study drug)
研究者
研究点 (1)
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