NCT04783753已完成1 期
A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, and Quinidine on the Pharmacokinetics and Safety of EDP-514 in Healthy 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
- 72
- 试验地点
- 1
- 主要终点
- Cmax of EDP-514 with and without coadministration with itraconazole
研究概览
简要总结
Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult subjects.
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.
- •Male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive
- •Female subjects who are heterosexually active and of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-
- •Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg.
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 clinically significant active infection.
- •A positive urine drug screen at Screening or Day -
- •Current tobacco smokers or use of tobacco products within 3 months prior to Screening.
- •Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
- •Clinically significant laboratory abnormalities at screening or Day -1, as determined by the Investigator (including but not limited to hypokalemia, hypocalcemia, or hypomagnesemia for Part 3 participants).
- •History of regular alcohol consumption
- •Participation in a clinical trial within 30 days prior to the first dose of study drug.
- •For Part 2 (Carbamazepine) participants:
- •Participants of Asian ancestry, given association of carbamazepine and severe rash (Stevens Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) with HLA-B 1502 in this population.
- •Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine.
研究组 & 干预措施
EDP-514 and Itraconazole interaction (Part 1)
Experimental
干预措施: Itraconazole (Drug)
EDP-514 and Itraconazole interaction (Part 1)
Experimental
干预措施: EDP-514 (Drug)
EDP-514 and Carbamazepine interaction (Part 2)
Experimental
干预措施: EDP-514 (Drug)
EDP-514 and Carbamazepine interaction (Part 2)
Experimental
干预措施: Carbamazepin (Drug)
EDP-514 and Quinidine interaction (Part 3)
Experimental
干预措施: EDP-514 (Drug)
EDP-514 and Quinidine interaction (Part 3)
Experimental
干预措施: Quinidine (Drug)
结局指标
主要结局
Cmax of EDP-514 with and without coadministration with itraconazole
时间窗: up to 19 days
Cmax of EDP-514 with and without coadministration with carbamazepine
时间窗: up to 28 days
AUC of EDP-514 with and without coadministration with carbamazepine
时间窗: up to 28 days
Cmax of EDP-514 with and without coadministration with quinidine
时间窗: up to 13 days
AUC of EDP-514 with and without coadministration with quinidine
时间窗: up to 13 days
AUC of EDP-514 with and without coadministration with itraconazole
时间窗: 19 days
次要结局
- Safety measured by adverse events(up to 34 days)
研究者
研究点 (1)
Loading locations...
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