NCT05320861已完成1 期
A Single Dose Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]SJP-0008 in Healthy Male Subjects After an Oral Dose
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
- Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]SJP-0008
研究概览
简要总结
This single centre, open-label, non-randomised, single period, single-dose study in healthy male subjects was designed and conducted to assess the mass balance recovery, PK, metabolite profile and metabolite identification of SJP-0008.
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
- 50 Years 至 70 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 as measured at screening
- •Must be willing and able to communicate and participate in the whole study
- •Must have regular bowel movements
- •Must provide written informed consent
- •Must agree to adhere to the contraception requirements of the protocol
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, or are immediate family members of, a study site or sponsor employee
- •Subjects who report to have previously received SJP-0008
- •Evidence of current SARS-CoV-2 infection
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption in males >21 units per week
- •A confirmed positive alcohol breath test at screening or admission
- •Current smokers and those who have smoked within the last 6 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
- •Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 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
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
[14C]SJP-0008
Experimental
干预措施: [14C]SJP-0008 (Drug)
结局指标
主要结局
Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]SJP-0008
时间窗: Until the mass balance criteria for all participants have been met (estimated up to Day 10)
Mass balance recovery of total radioactivity in all excreta by analysing the total radioactivity and metabolic profile in plasma, urine and faeces samples.
次要结局
- Maximum plasma concentration (Cmax) of SJP-0008 and SNJ-2026(Up to Day 8)
- Area under the concentration-time curve from time zero to last measurable concentration (AUC0-last) of SJP-0008 and SNJ-2026(Up to Day 8)
- Area under the concentration-time curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) of SJP-0008 and SNJ-2026(Up to Day 8)
- Area under concentration-time curve from time zero to infinity (AUC0-inf) of SJP-0008 and SNJ-2026(Up to Day 8)
- Time to maximum plasma concentration (Tmax) of SJP-0008 and SNJ-2026(Up to Day 8)
- Half-life (T1/2) of SJP-0008 and SNJ-2026(Up to Day 8)
- First order rate constant associated with the terminal (log-linear) portion of the curve (Lambda-z) of SJP-0008 and SNJ-2026(Up to Day 8)
- Percentage of participants with adverse events (AEs)(Until the mass balance criteria for all participants have been met (estimated up to Day 10))
研究者
研究点 (1)
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