A Non-Randomized, Multiple-Dose, Open-Label, Single Sequence Study to Evaluate the Effect of Concomitant Administration of EDP-323 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323
研究概览
简要总结
The primary aim of this study is to assess the effect of EDP-323 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older 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 65 years, inclusive
- •Screening body weight >50 kg and body mass index (BMI) of 18 to 32 kg/m2
- •Female subjects 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-
- •A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.
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
- •Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
- •Positive for HIV or hepatitis
- •Positive urine drug screen
- •Current tobacco smokers or use of tobacco within 3 months prior to Screening.
- •Received any vaccine, an investigational agent, or biological product within 28 days or 5 times the t½ of receipt of study drug, whichever is longer.
- •Drug sensitivity to midazolam, caffeine, rosuvastatin
研究组 & 干预措施
EDP-323, midazolam, caffeine and rosuvastatin
Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days
干预措施: EDP-323 (Drug)
EDP-323, midazolam, caffeine and rosuvastatin
Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days
干预措施: Midazolam (Drug)
EDP-323, midazolam, caffeine and rosuvastatin
Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days
干预措施: Caffeine (Drug)
EDP-323, midazolam, caffeine and rosuvastatin
Subjects will receive EDP-323, midazolam, caffeine and rosuvastatin throughout the treatment period on respective dosing days
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323
时间窗: Up to 17 Days
AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-323
时间窗: Up to 17 Days
次要结局
- Safety measured by adverse events(Up to 22 days)