A Phase 1, Open-Label Study to Characterize the Absorption, Metabolism, Excretion (ADME), and Mass Balance of a Single Oral Dose of [14C]-RPT193 in Healthy Adult 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
- Characterize pharmacokinetics (PK) profile of RPT193
研究概览
简要总结
Phase 1, open-label, absorption, metabolism, excretion, and mass balance study.
详细描述
A study of RPT193 in healthy volunteers to evaluate the route(s) of elimination and overall mass balance of RPT193 in urine and feces
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
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening
排除标准
- •Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit
- •History or presence of clinically significant medical or psychiatric condition or disease
- •History or presence of alcohol or drug abuse within the past 2 years prior to dosing
- •History or presence of:
- •Gastrointestinal ulcers, or history of other significant GI diseases
- •Malignancy within the last 5 years, with the exception of successfully treated basal cell carcinoma.
- •Clinically significant history of angina, myocardial infarction, syncope, clinically significant cardiac arrhythmias, left ventricular hypertrophy, cardiomyopathy, or any other cardiovascular abnormality
- •Ongoing or recent (within 30 days prior to RPT193 administration) bacterial, fungal, or viral infection requiring therapy
- •Known family history of sudden death.
- •Positive for human immunodeficiency virus, hepatitis B, hepatitis C
- •Unwilling to abstain from alcohol, xanthane-containing beverages or food or foods containing grapefruit/Seville orange prior to admission
- •Received radiolabeled substances or exposed to radiation sources over past 12 months
研究组 & 干预措施
14C RPT193 400 mg
Radiolabelled RPT193
干预措施: 14C RPT193 (Drug)
结局指标
主要结局
Characterize pharmacokinetics (PK) profile of RPT193
时间窗: 14 days
Calculation of elimination constant in plasma and urine
Route(s) of elimination 1
时间窗: 14 days
Amount (in mass equivalents of parent drug) of radioactive drug excreted as TRA in urine and feces
Route(s) of elimination 2
时间窗: 14 days
Percent (%) of radioactive drug excreted as TRA in urine and feces
Quantitate total radioactivity (TRA)
时间窗: 14 days
Percent (%) of each drug-related material (parent and each metabolite) in whole blood, plasma, urine and feces
次要结局
未报告次要终点