A Study to Evaluate the Mass Balance and Absolute Bioavailability of [14C]JMKX003142 in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
- 主要终点
- Mass balance of JMKX003142
研究概览
简要总结
A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral JMKX003142. The study will be conducted in two parts: Part 1 to assess the mass balance of JMKX003142 using orally administered radiolabelled JMKX003142; part 2 will assess the absolute bioavailability using JMKX003142 and radiolabelled JMKX003142 as intravenous and oral forms
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Chinese healthy males.
- •The age between 18 and 45 years (extremes included), on the date of signing the informed consent form (ICF).
- •Body mass index (BMI) range of 19-26.0 kg/m² (inclusive of boundary values), with body weight not less than 55.0 kg.
排除标准
- •Abnormal findings with clinical significance on comprehensive physical examination, vital signs, digital rectal examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis, fecal routine with occult blood, thyroid function), ophthalmological examination, 12-lead electrocardiogram, chest X-ray (posteroanterior view), and abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys).
- •White blood cell count and/or hemoglobin below the lower limit of the normal range in complete blood count.
- •Resting corrected QT interval (QTcF) >450 ms (corrected by Fridericia's formula, QTcF = QT/RR^1/3).
- •Hepatitis B surface antigen or E antigen positive, anti-HCV IgG positive, syphilis treponemal antibody positive, and HIV antigen/antibody combination test positive.
- •Subjects with gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, or those with a history of severe vomiting or diarrhea within one week prior to screening.
研究组 & 干预措施
Part1: Mass Balance
Participants will receive oral [14C] JMKX003142 under fasted conditions
干预措施: [14C]JMKX003142 (Drug)
Part2: Absolute Bioavailability
Participants will receive oral JMKX003142 under fasted conditions, followed by intravenous IV [14C]
干预措施: JMKX003142 tablets (Drug)
Part2: Absolute Bioavailability
Participants will receive oral JMKX003142 under fasted conditions, followed by intravenous IV [14C]
干预措施: [14C]JMKX003142 solution for infusion (Drug)
结局指标
主要结局
Mass balance of JMKX003142
时间窗: up to 15 days (until >90% of dose is recovered)
Total recovery of radioactivity in urine and faeces following a single oral dose of \[14C\]-JMKX003142 (expressed as a percentage of the total radioactive dose administered)
Absolute bioavailability of JMKX003142 in plasma
时间窗: 96 hours
Absolute bioavailability is calculated from the AUCs of iv and oral administration
次要结局
- Part1: Maximum Concentration (Cmax) of JMKX003142 in Plasma(Day 1 to day 15 (depending on recovery of dose))
- Frequency and severity of Participants With Adverse Events (AEs)(Up to Day 30)
- Part1: Time to Reach Maximum Concentration (tmax) of JMKX003142 in Plasma(Day 1 to day 15 (depending on recovery of dose))
- Part1: Apparent Terminal Half-Life (t1/2) Of JMKX003142(Day 1 to day 15 (depending on recovery of dose))
- Part1: Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of JMKX003142 in Plasma(Day 1 to day 15 (depending on recovery of dose))