NCT04927793已完成1 期
A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]EDP-938 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-938 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-938 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
- •Males of any ethnic origin, between 18 and 55 years of age, 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 (check-in only), 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, including cholecystectomy, that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- •a. Subjects with a history of cholecystitis, cholelithiasis, and/or choledocholithiasis will also be excluded.
- •Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- •A body surface area-adjusted estimated glomerular filtration rate (eGFR) ≤ 90 mL/min per 1.73 m2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, at screening
研究组 & 干预措施
Single arm EDP-938
Experimental
干预措施: EDP-938 (Drug)
结局指标
主要结局
Cmax of EDP-938 in plasma
时间窗: Up to 11 days
AUC0-tlast of EDP-938 in plasma
时间窗: Up to 11 days
AUC-inf in plasma
时间窗: Up to 11 days
Amount excreted in urine (Aeu)
时间窗: Up to 11 days
Amount excreted in feces (Aef)
时间窗: Up to 11 days
Cmax of EDP-938 metabolites in plasma
时间窗: Up to 11 days
次要结局
- Safety measured by occurrence of adverse events(Up to 11 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male SubjectsHealthy VolunteersNCT05657834Sagimet Biosciences Inc.8
已完成
1 期
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male SubjectsNASH - Nonalcoholic SteatohepatitisNCT03748628Enanta Pharmaceuticals, Inc8
已完成
1 期
A Study to Evaluate the Absorption, Metabolism, and Excretion and Absolute Bioavailability of Xevinapant in Healthy Male ParticipantsHealthy VolunteersNCT04962724Debiopharm International SA12
已完成
1 期
Study to Assess the Absorption, Metabolism, Excretion and Pharmacokinetics of [14C]-AKB-9778HealthyNCT02858271Aerpio Therapeutics6
进行中（未招募）
早期 1 期
Absorption, Metabolism, and Excretion of CYC065 in Healthy Male SubjectsHealthyNCT05817890Cyclacel Pharmaceuticals, Inc.8