NCT03748628已完成1 期
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]EDP-305 Following a Single Oral Dose in Healthy Male Subjects
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
- 8
- 试验地点
- 1
- 主要终点
- Cmax of EDP-305 in plasma
研究概览
简要总结
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-305 in healthy male subjects.
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
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged between 18 and 55 years (inclusive) with a body mass index between 18.0 and 32.0 kg/m2 (inclusive)
- •able to comprehend and willing to sign an Informed Consent Form
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations.
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (including gastrectomy and cholecystectomy; uncomplicated appendectomy and hernia repair will be allowed).
- •Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
研究组 & 干预措施
Single arm EDP-305
Experimental
干预措施: EDP-305 (Drug)
结局指标
主要结局
Cmax of EDP-305 in plasma
时间窗: Up to 9 days
AUC of EDP-305 in plasma
时间窗: Up to 9 days
AUC-inf in plasma
时间窗: Up to 9 days
次要结局
- Amount excreted in urine (Aeu)(Up to 9 days)
- Amount excreted in feces (Aef)(Up to 9 days)
- Safety measured by adverse events(Up to 9 days)
研究者
研究点 (1)
Loading locations...
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