An Open Label, Single-Dose, Single Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-A4250 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Albireo
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Metabolite profiling of A4250 of faeces using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate
研究概览
简要总结
The primary objectives of the study are to assess the mass balance recovery after a single dose of carbon-14 [14C]-A4250 as a capsule and to provide plasma, urine and faecal samples for metabolite profiling and structural identification in 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
- Treatment
- 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
- •Healthy males
- •Age 30 to 65 years of age
- •Body mass index of 18.0 to 35.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- •Must be willing and able to communicate and participate in the whole study
- •Must have regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
- •Must provide written informed consent
- •Must agree to use an adequate method of contraception
排除标准
- •Subjects who have received any IMP in a clinical research study within the previous 3 months prior to screening
- •Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- •Subjects who have previously been enrolled in this study
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- •Current smokers and those who have smoked within the last 12 months. A confirmed positive urine cotinine test at screening or admission
- •Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •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 1999, shall participate in the study
- •Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
- •Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- •Confirmed positive drugs of abuse test result at screening or admission
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- •Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <90 mL/min using the Cockcroft-Gault equation
- •History of cardiovascular, renal, hepatic, chronic respiratory or GI disease as judged by the investigator
- •Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- •Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
- •Donation or loss of greater than 400 mL of blood within the previous 3 months
- •Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
- •Failure to satisfy the investigator of fitness to participate for any other reason
研究组 & 干预措施
3 mg [14C]-A4250 capsule
干预措施: 3 mg [14C]-A4250 capsule (Drug)
结局指标
主要结局
Metabolite profiling of A4250 of faeces using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate
时间窗: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))
Identification of the chemical structure of each metabolite accounting for greater than 10% of the dose in faeces
To assess mass balance recovery of total radioactivity in urine
时间窗: Between pre-dose (admission to 0 hour) and post dose (ending on morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))
Amount excreted (Ae) and Ae as a percentage of the administered dose (% Ae), cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
To assess mass balance recovery of total radioactivity in faeces
时间窗: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))
Amount excreted (Ae) and Ae as a percentage of the administered dose (% Ae), cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
Metabolite profiling of A4250 of plasma using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate
时间窗: Between pre-dose and up to 48 hours post dose
Identification of the chemical structure of each metabolite accounting for greater than 10% of circulating radioactivity in plasma
Metabolite profiling of A4250 of urine using liquid-chromatography-radio-detection with subsequent mass spectrometry as appropriate
时间窗: Between pre-dose (admission to 0 hour) and post dose (ending on the morning of discharge (up to day 10 depending on if mass balance cumulative recovery >90% or <1% of dose has been collected))
Identification of the chemical structure of each metabolite accounting for greater than 10% of the dose in urine
次要结局
未报告次要终点