NCT04952467已完成1 期
An Open Label, Single-dose, Single-period Study to Assess the Pharmacokinetics, Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-XEN1101 in Healthy Male Subjects
适应症
干预措施
相关药物
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
- Total radioactivity excreted in urine and faeces following oral administration of XEN1101
研究概览
简要总结
This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-XEN1101 in healthy adult 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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 18.0 to 32.0 kg/m2
- •Must be willing and able to communicate and participate in the whole study
- •Provide written informed consent
- •Adhere to the specified contraception requirements
排除标准
- •Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 90 days
- •Evidence of any current infection or an infection within 14 days before study drug administration
- •History of any drug or alcohol abuse in the past 2 years
- •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 millisievert (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 a clinical trial involving administration of radiolabelled compound(s) within 180 days of the planned dosing date of this study
- •Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis. Subjects with Gilbert's Syndrome will be excluded.
- •Confirmed positive drugs of abuse test result
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
- •History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
- •Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
研究组 & 干预措施
Drug: (14C)-XEN1101
Experimental
Subjects will receive oral 14C-XEN1101 under fed conditions.
干预措施: 14C-XEN1101 (Drug)
结局指标
主要结局
Total radioactivity excreted in urine and faeces following oral administration of XEN1101
时间窗: From Screening up to Day 57 post-dose
Cumulative amount of total radioactivity excreted in urine and feces combined (CumAe(total)) and expressed as a % of the radioactive dose administered (Cum%Ae(total)) following oral administration of 14C-XEN1101
次要结局
- Plasma whole blood concentration ratios for total radioactivity(From Screening up to Day 57 post-dose)
- Pharmacokinetic (PK) data for 14C-XEN1101; Tmax(From Screening up to Day 57 post-dose)
- PK data for 14C-XEN1101; Cmax(From Screening up to Day 57 post-dose)
- 14C Metabolite profiling in of plasma, urine and feces(From Screening up to Day 57 post-dose)
- PK data for 14C-XEN1101; T1/2(From Screening up to Day 57 post-dose)
- Mass balance data for 14C-XEN1101 in urine(From Screening up to Day 57 post-dose)
- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations(From Screening up to Day 57 post-dose)
- Mass balance data for 14C-XEN1101 in feces(From Screening up to Day 57 post-dose)
研究者
研究点 (1)
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