NCT03213145已完成1 期
A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin 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 itraconazole
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 itraconazole or rifampin 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.
研究组 & 干预措施
Part 1
Experimental
干预措施: intraconazole (Drug)
Part 1
Experimental
干预措施: EDP 305 (Drug)
Part 2
Experimental
干预措施: Rifampin (Drug)
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 itraconazole
时间窗: Up to 19 days
Cmax of EDP-305 with and without coadministration with rifampin
时间窗: Up to 17 days
AUC of EDP-305 with and without coadministration with itraconazole
时间窗: Up to 19 days
AUC of EDP-305 with and without coadministration with rifampin
时间窗: Up to 17 days
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).(Up to 19 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy VolunteersNASH - Nonalcoholic SteatohepatitisNCT03610945Enanta Pharmaceuticals, Inc48
已完成
1 期
Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy VolunteersDrug-drug InteractionAutoimmune DiseasesFibrotic DiseaseNCT03530995Kadmon Corporation, LLC73
已完成
1 期
Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy SubjectsRSV InfectionNCT03755778Enanta Pharmaceuticals, Inc72
已完成
1 期
THE EFFECT OF MULTIPLE DOSES OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL MIDAZOLAM DOSE IN HEALTHY PARTICIPANTSHealthy VolunteerNCT03916406Pfizer10
已完成
1 期
Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult SubjectsRSV InfectionNCT03750383Enanta Pharmaceuticals, Inc48