A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-YH4808 Following Single Oral Dose Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- PK of a single oral dose of [14C] YH4808 200 mg and its metabolites(M3, M8)
研究概览
简要总结
The purpose of this study is to determine the absorption, metabolism, and excretion (AME) kinetics of YH4808 and to determine and characterize metabolites present in plasma, urine, and feces in man following a single dose of [14C] YH4808 200 mg (~100 µCi ±20 µCi) administered as a single oral dose.
详细描述
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to Study Entry (ie, prior to Check-in [Day -1]). Subjects will be confined at the Clinical Research Unit (CRU) from Check in (Day -1) until Discharge Criteria have been met (as early as Day 6 and as late as Day 11). In this study design, physical examinations, electrocardiograms (ECGs), vital signs, How do you feel? (HDYF?) Inquiries, and clinical laboratory evaluations will be performed at Screening, at specified times during the study, and/or at Clinic Discharge. All AEs, whether volunteered, elicited, or noted on physical examination, will be recorded throughout the study (ie, from dosing on Day 1 until Clinic Discharge [Day 11]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •clinical laboratory evaluations within the reference range for the test laboratory
- •negative test for selected drugs of abuse, hepatitis panel and HIV antibody screens
- •able to comprehend and willing to sign an Informed Consent Form
排除标准
- •significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- •history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- •participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in
- •donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion, inclusive
研究组 & 干预措施
[14C]-YH4808 200 mg
[14C]-YH4808 200 mg
干预措施: [14C]-YH4808 200 mg (Drug)
结局指标
主要结局
PK of a single oral dose of [14C] YH4808 200 mg and its metabolites(M3, M8)
时间窗: Day1-Day11
* Maximum observed concentration in plasma, whole blood, urine, and feces * Time to maximum observed concentration in plasma, whole blood, urine, and feces * Area under the concentration-time curve from Hour 0 to the last measurable concentration * Assessment of Mass balance
次要结局
- Characterization and identification of metabolites of [14C]-YH4808 in plasma, urine, and feces(Day1-Day11)
- assessment of the safety and tolerability of YH4808(Day1-Day11)