An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability of Aramchol and to Determine the Mass Balance Recovery, Metabolite Profile and Metabolite Identification to Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Metabolite profiling
研究概览
简要总结
A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for [14C]-aramchol in healthy male subjects
详细描述
A two-part open-label study to assess the absolute bioavailability of aramchol and the mass balance recovery, metabolite profile and identification of metabolite structures for [14C]-aramchol in healthy male subjects.
A subject was considered evaluable in Part 1 if they provided PK samples for up to a minimum of 120 h after first investigational medicinal product (IMP) administration. A subject was considered evaluable in Part 2 if they provided biological samples for up to a minimum of 144 h after IMP administration or demonstrated >90% mass balance recovery, or <1% of the administered dose eliminated in excreta for 2 consecutive days, whichever was sooner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Aged 35 to 64 years at the time of signing informed consent
- •Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening
- •Must be willing and able to communicate and participate in the whole study
- •Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
- •Must provide written informed consent
- •Must agree to adhere to the contraception requirements
排除标准
- •Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
- •Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
- •A confirmed positive alcohol breath test at screening or each admission
- •Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or each admission
- •Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •Subjects with pregnant or lactating partners
- •Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
- •Participation in any study involving administration of any [14C]-labelled compound within 12 months prior to dosing in Part 1 of this study
研究组 & 干预措施
Single dose administration of Aramchol in Part 1 and Part 2
6 subjects received Aramchol in Part 1 and Part 2 of the study
干预措施: Aramchol (Drug)
结局指标
主要结局
Metabolite profiling
时间窗: 10 days
Assess the potential metabolites of Aramchol and determine their chemical structure in plasma, urine and fecal samples
Mass balance recovery
时间窗: 10 days
Assess the mass balance recovery of total amounts of radioactivity excreted in urine and feces
Absolute bioavailability
时间窗: 10 days
Measure the AUC(0-inf) of orally and intravenously (IV) administered Aramchol
次要结局
- PK- Maximum observed concentration (Cmax)(10 days)
- Chemical structure of each metabolite accounting for more than 10%(10 days)
- Safety- Clinical laboratory parameters(10 days)
- Routes and rates of elimination(10 days)
- Safety- Adverse events(10 days)
- PK- Area under the concentration-time curve (AUC)(10 days)
- PK- Total body clearance (CL)(10 days)
- PK- Time of maximum observed concentration (Tmax)(10 days)