A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of EDP-938 on the Pharmacokinetics of Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Cmax of tacrolimus with and without coadministration with EDP-938
研究概览
简要总结
A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of tacrolimus, dabigatran, rosuvastatin and midazolam on the Pharmacokinetics and Safety of EDP-938 in Healthy 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.
- •Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
- •Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
- •Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.
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.
- •For Part 1 subjects:
- •Clinical history or evidence at Screening consistent with hyperkalemia, hypertension and/or diabetes mellitus
- •For Part 2 Subjects:
- •Clinical history or evidence at screening of medically significant bleeding
- •History of a mechanical heart valve placement, a thromboembolic event or clinically significant thrombotic event, an autoimmune disease, eg, systemic lupus erythematosus (SLE), or recurrent spontaneous abortions
- •A platelet count <LLN, or INR >ULN, or aPTT > ULN at Screening
- •Ongoing daily use of nonsteroidal anti-inflammatory drugs
- •For Part 3 subjects:
- •AST and/or ALT >ULN at Screening
- •For Part 4 subjects:
- •History of glaucoma
研究组 & 干预措施
EDP-938 and tacrolimus interaction (Part 1)
干预措施: EDP-938 (Drug)
EDP-938 and tacrolimus interaction (Part 1)
干预措施: Tacrolimus (Drug)
EDP-938 and dabigatran interaction (Part 2)
干预措施: EDP-938 (Drug)
EDP-938 and dabigatran interaction (Part 2)
干预措施: Dabigatran (Drug)
EDP-938 and rosuvastatin interaction (Part 3)
干预措施: EDP-938 (Drug)
EDP-938 and rosuvastatin interaction (Part 3)
干预措施: Rosuvastatin (Drug)
EDP-938 and midazolam interaction (Part 4)
干预措施: EDP-938 (Drug)
EDP-938 and midazolam interaction (Part 4)
干预措施: Midazolam (Drug)
结局指标
主要结局
Cmax of tacrolimus with and without coadministration with EDP-938
时间窗: up to 29 days
Cmax of dabigatran with and without coadministration with EDP-938
时间窗: up to 17 days
AUC of tacrolimus with and without coadministration with EDP-938
时间窗: up to 29 days
Cmax of rosuvastatin with and without coadministration with EDP-938
时间窗: up to 17 days
AUC of midazolam with and without coadministration with EDP-938
时间窗: up to 17 days
AUC of dabigatran with and without coadministration with EDP-938
时间窗: up to 17 days
Cmax of midazolam with and without coadministration with EDP-938
时间窗: up to 17 days
AUC of rosuvastatin with and without coadministration with EDP-938
时间窗: up to 17 days
次要结局
- Safety measured by adverse events(up to 34 days)