A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine, and Fluconazole on the Pharmacokinetics and Safety of EDP-323 in Healthy Participants
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-323 with and without coadministration with Itraconazole
研究概览
简要总结
The primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety of EDP-323 in healthy adult participants. Each participant's duration in the study will be dependent upon which study part they are enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of50 kg
- •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
- •A positive urine drug screen at Screening or Day -1
- •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 exceeding protocol limits
- •Participation in a clinical trial within 28 days prior to the first dose of study drug
- •For Part 2 and Part 3 participants, 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
- •Other exclusions for Part 2 (carbamazepine) participants
- •Participants of Asian ancestry with HLA allele 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-323 and itraconazole interaction (Part 1)
Subjects will receive EDP-323 and itraconazole on respective dosing days
干预措施: EDP-323 (Drug)
EDP-323 and itraconazole interaction (Part 1)
Subjects will receive EDP-323 and itraconazole on respective dosing days
干预措施: Itraconazole (Drug)
EDP-323 and carbamazepine interaction (Part 2)
Subjects will receive EDP-323 and carbamazepine on respective dosing days
干预措施: EDP-323 (Drug)
EDP-323 and carbamazepine interaction (Part 2)
Subjects will receive EDP-323 and carbamazepine on respective dosing days
干预措施: carbamazepine (Drug)
EDP-323 and quinidine interaction (Part 3)
Subjects will receive EDP-323 and quinidine on respective dosing days
干预措施: EDP-323 (Drug)
EDP-323 and quinidine interaction (Part 3)
Subjects will receive EDP-323 and quinidine on respective dosing days
干预措施: Quinidine (Drug)
EDP-323 and fluconazole interaction (Part 4)
Subjects will receive EDP-323 and fluconazole on respective dosing days
干预措施: EDP-323 (Drug)
EDP-323 and fluconazole interaction (Part 4)
Subjects will receive EDP-323 and fluconazole on respective dosing days
干预措施: fluconazole (Drug)
结局指标
主要结局
Cmax of EDP-323 with and without coadministration with Itraconazole
时间窗: Day 1 through Day 19
AUC of EDP-323 with and without coadministration with Itraconazole
时间窗: Day 1 through Day 19
Cmax of EDP-323 with and without coadministration with Carbamazepine
时间窗: Day 1 through Day 28
AUC of EDP-323 with and without coadministration with Carbamazepine
时间窗: Day 1 through Day 28
Cmax of EDP-323 with and without coadministration with Quinidine
时间窗: Day 1 through Day 13
AUC of EDP-323 with and without coadministration with Quinidine
时间窗: Day 1 through Day 13
Cmax of EDP-323 with and without coadministration with fluconazole
时间窗: Day 1 through Day 19
AUC of EDP-323 with and without coadministration with fluconazole
时间窗: Day 1 through Day 19
次要结局
- Safety measured by adverse events(Up to 34 Days)