NCT05238714已完成1 期
An Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-Venglustat (2.67 MBq) in Healthy Male Subjects
Genzyme, a Sanofi Company1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年5月26日最近更新:
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
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Percentage of radioactive dose excreted in urine and faeces
研究概览
简要总结
Primary Objectives:
- To determine the excretion balance and systemic exposure of radioactivity after oral administration of [14C]-venglustat.
- To determine the pharmacokinetics (PK) of venglustat and its contribution to the overall exposure of radioactivity.
- To determine the metabolic pathways, metabolite profile, chemical structures and main excretion route of the main venglustat metabolites and the metabolite contribution to the overall exposure of radioactivity.
Secondary Objective:
To assess the clinical and biological tolerability of oral solution of venglustat
详细描述
43 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight between 50.0 and 100.0 kg, inclusive, body Mass Index 18 to 32 kg/m2, inclusive
- •Certified as healthy by a comprehensive clinical assessment
- •Normal vital signs after 10 minutes resting in supine position
- •Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position in the following ranges; 120 ms≤PR≤230 msec, QRS≤120 msec, QTc≤450 msec and normal ECG tracing unless the Investigator considers an ECG tracing abnormality to be not clinically relevant
- •Laboratory parameters within the normal range
- •Having given written informed consent prior to undertaking any study-related procedure
- •Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
- •Not under any administrative or legal supervision
- •Normal renal function as expressed by a creatinine clearance >80 mL/min as calculated by the Cockroft and Gault formula
- •Male subjects who agree to use condoms, whose female partner(s) are of childbearing potential (including lactating women), must accept to use, during sexual intercourse, a double contraception method (unless they underwent surgical sterilization) until 90 days after the end of study
排除标准
- •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for vomiting only: more than twice a month).
- •Blood donation, any volume, within 3 months before inclusion.
- •Symptomatic postural hypotension, irrespective of the decrease in blood pressure.
- •Presence or history of clinically significant drug hypersensitivity, or allergic disease diagnosed and treated by a physician that in the opinion of the Investigator would compromise subject safety.
- •History or presence of drug or alcohol abuse (alcohol consumption more than 14 units per week on a regular basis) in the 5 years prior to screening.
- •Smoking or using nicotine replacement products or e-cigarettes regularly more than 5 cigarettes or equivalent per week, unable to stop smoking during the study (occasional smoker can be enrolled).
- •Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day)
- •Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination or any medications known to be CYP3A4 inducers within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion
- •Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the Investigator at screening.
- •Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- •Any subject enrolled in or having participated, in [this or] any other clinical study involving an investigational medicinal product (IMP) according to applicable regulations/guidelines in the 3 months prior to dosing of this study.
- •Any subject who cannot be contacted in case of emergency.
- •Any subject who is the Investigator or any sub investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study
- •Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
- •Confirmed positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, tricyclic antidepressants, opiates including methadone).
- •Positive alcohol breath test
- •Any subject with specific dietary habits, such as vegan.
- •Any subject with irregular bowel habits (more than 3 bowel movements/day or less than 1 every 2 days).
- •Any subject undergoing dental care or presenting with dental caries.
- •Any subject who is occupationally exposed to radiation as defined in the Ionizing Radiations Regulations 2017
- •Participation in a trial with 14C-radiolabelled medication in the 12 months preceding the study.
- •Radiation exposure, including that from the present study and radiopharmaceuticals or radionuclides in therapeutic or diagnostic procedures, but excluding background radiation, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years.
- •Any consumption of citrus (grapefruit, orange, etc) or their juices within 5 days before inclusion
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
[14C] venglustat
Experimental
Single dose of [14C] venglustat Oral Solution under fasting conditions
干预措施: venglustat (Drug)
结局指标
主要结局
Percentage of radioactive dose excreted in urine and faeces
时间窗: Day -1 up to max Day 43
Percentage of radioactive dose excreted in urine and faeces
Cmax of plasma and blood radioactivity
时间窗: Day 1 up to max Day 43
Maximum plasma or blood concentration observed
AUC Last of plasma and blood radioactivity
时间窗: Day 1 up to max Day 43
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time, tlast (time corresponding to the last concentration above the limit of quantification, Clast)
AUC Last of plasma venglustat
时间窗: Day 1 up to max Day 43
tmax of plasma and blood radioactivity
时间窗: Day 1 up to max Day 43
Time to Cmax
tmax of plasma venglustat
时间窗: Day 1 up to max Day 43
Time to reach Cmax
次要结局
- Percentage of venglustat metabolites in plasma(Day 1 up to max Day 43)
- Percentage of venglustat metabolites in urine(Day 1 up to max Day 43)
- Percentage of venglustat metabolites in faeces(Day 1 up to max Day 43)
- Number of participants with adverse events (AEs)(Day 1 up to max Day 43)
研究者
研究点 (1)
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