An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-AK0529 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Amount excreted (Ae)
研究概览
简要总结
This phase I study is to assess the mass balance recovery after a single oral dose of [14C]-AK0529 in healthy male subjects.
详细描述
This is a single centre, single-dose, non-randomised, open label study. The primary objectives of this study are to assess the mass balance recovery and provide biosamples for metabolite profiling and structural identification after a single oral dose of [14C]-AK0529 in healthy male subjects. 7 subjects will be recruited to receive a single oral administration of a solution containing 300 mg AK0529. The total duration of the study will be approximately 6 weeks.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males
- •Aged between 30 and 55 years of age, inclusive
- •Body mass index of 18.0 to 35.0 kg/m2, inclusive, or, if outside the range, considered not clinically significant by the investigator and the medical monitor
- •Must be willing and able to communicate and participate in the whole study
- •Must have regular daily bowel movements
- •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
- •Subjects who are study site or sponsor 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 >21 units per week
- •Current smokers and those who have smoked within the last 12 months
- •Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •Radiation exposure. 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
- •Abnormal liver function as assessed by clinical chemistry
- •Positive drugs of abuse test result
- •Positive HBsAg, HCV Ab or HIV results
- •Evidence of renal impairment at screening
- •History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, neurological, dermatological or GI disease, or psychiatric disorder, as judged by the investigator
- •Any abnormality of ECG parameters
- •Any abnormality of cardiac rhythm or history thereof
- •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 at screening or admission
- •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 or herbal or any other 'alternative' remedies in the 14 days before IMP administration
- •Failure to satisfy the investigator of fitness to participate for any other reason
研究组 & 干预措施
Intervention Arm
Each subject will receive a single oral administration of a solution containing 300 mg radiolabeled AK0529 in the fasted state.
干预措施: AK0529 (Drug)
结局指标
主要结局
Amount excreted (Ae)
时间窗: At approximately 6 weeks
The amount of total radioactivity eliminated.
Percentage of cumulative recovery of the administered dose (Cum%Ae)
时间窗: At approximately 6 weeks
The cumulative amount of total radioactivity eliminated expressed as a percentage of the dose administered.
Percentage of the administered dose (%Ae)
时间窗: At approximately 6 weeks
The amount of total radioactivity eliminated expressed as a percentage of the dose administered.
Cumulative recovery (CumAe)
时间窗: At approximately 6 weeks
The cumulative amount of total radioactivity eliminated.
次要结局
- Percentage of Subjects with Adverse Events (AEs)(From baseline up to approximately 6 weeks)