NCT03610945已完成1 期
A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole and Quinidine on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers
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
- 48
- 试验地点
- 1
- 主要终点
- Cmax of EDP-305 with and without coadministration with fluconazole
研究概览
简要总结
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •An informed consent document signed and dated by the subject.
- •Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
- •Female subjects must be of non-childbearing potential.
排除标准
- •Clinically relevant evidence or history of illness or disease.
- •Pregnant or nursing females.
- •History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- •A positive urine drug screen at screening or Day -
- •Current tobacco smokers or use of tobacco within 3 months prior to screening.
- •Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
- •History of regular alcohol consumption.
- •Participation in a clinical trial within 30 days prior to the first dose of study drug.
- •Clinically significant electrocardiogram abnormalities or QTcF greater than 450 ms for males and 470 ms for females at either Screening or Day -1 (Part 2 only), or any prior history of QT abnormality.
- •For Part 2 subjects, the following cardiovascular abnormalities
- •QRS duration >110 ms
- •Incomplete right bundle branch block or any complete bundle branch block
- •Heart rate <40 or >90 beats per minute (per vital sign capture while rested)
- •History of unexplained syncope, structural heart disease, or clinically significant arrhythmias
- •Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome
- •PR interval >220 ms or any 2nd or 3rd degree AV block
- •Ventricular pre-excitation
研究组 & 干预措施
EDP-305 and fluconazole interaction (Part 1)
Experimental
干预措施: Fluconazole (Drug)
EDP-305 and fluconazole interaction (Part 1)
Experimental
干预措施: EDP-305 (Drug)
EDP-305 and quinidine interaction (Part 2)
Experimental
干预措施: Quinidine (Drug)
EDP-305 and quinidine interaction (Part 2)
Experimental
干预措施: EDP-305 (Drug)
结局指标
主要结局
Cmax of EDP-305 with and without coadministration with fluconazole
时间窗: Up to 19 days
AUC of EDP-305 with and without coadministration with fluconazole
时间窗: Up to 19 days
Cmax of EDP-305 with and without coadministration with quinidine
时间窗: Up to 13 days
AUC of EDP-305 with and without coadministration with quinidine
时间窗: Up to 13 days
次要结局
- Safety measured by adverse events(Up to 25 days)
研究者
研究点 (1)
Loading locations...
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