NCT03207425已完成1 期
A Phase 1, Open-Label, Parallel Group, Single Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of EDP 305 in Subjects With Varying Degrees of Hepatic Function
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
- 29
- 试验地点
- 3
- 主要终点
- Cmax of EDP 305
研究概览
简要总结
This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand and willing to sign the ICF and able to comply with the study restrictions
- •Adult male or female subjects age 18 to 75 years, inclusive, at the time of informed consent
- •Female subjects must be non-childbearing potential
- •Additional criteria for hepatically impaired subjects
- •Confirmed diagnosis of cirrhosis due to parenchymal liver disease
- •Stable hepatic impairment, defined as no clinically significant change in disease status, as judged by the Investigator
排除标准
- •Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at Screening that the Investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer except for conditions associated with hepatic impairment in subjects with compromised hepatic function
- •Clinically significant renal disease
- •Additional criteria for hepatically impaired Subjects
- •History of esophageal bleeding within the last 3 months prior to study drug administration
- •Severe hepatic encephalopathy (Grade >2) or degree of central nervous system (CNS) impairment
- •History of liver transplantation
- •Presence of Hepatocellular Carcinoma, or suspicion of Hepatocellular Carcinoma based on Investigator's judgment
- •Hepato-renal or hepato-pulmonary syndrome
- •Prior placement of a portosystemic shunt
- •Spontaneous bacterial peritonitis currently or within the last 6 months
- •Hospitalization within the last 2 months related to cirrhosis
- •Advanced ascites and ascites which require emptying and albumin supplementation, as judged by the Investigator
- •Hemoglobin concentration < 10.0 g/dL
研究组 & 干预措施
Mild hepatic impairment group
Experimental
干预措施: EDP 305 (Drug)
Moderate hepatic impairment group
Experimental
干预措施: EDP 305 (Drug)
Matching healthy control group
Experimental
Healthy control group will be matched with the hepatically impaired population with respect to age, sex and BMI
干预措施: EDP 305 (Drug)
结局指标
主要结局
Cmax of EDP 305
时间窗: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
AUCinf of EDP 305
时间窗: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
t1/2 of EDP 305
时间窗: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
CL/F of EDP 305
时间窗: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
次要结局
- Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).(From Screening up to Day 14)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment SubjectsRenal InsufficiencyNCT03235375MedImmune LLC37
已完成
2 期
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy VolunteersHepatic ImpairmentNCT01621633Novartis Pharmaceuticals32
已完成
1 期
Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal ImpairmentHCV InfectionNCT02402452Gilead Sciences20
已完成
1 期
Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic ImpairmentHepatic ImpairmentNCT04993157Novartis Pharmaceuticals54
已完成
1 期
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic ImpairmentChronic Hepatitis CNCT01817985Gilead Sciences33