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-235 IN HEALTHY PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cmax of EDP-235 with and without coadministration with Carbamazepine
研究概览
简要总结
A Drug-Drug Interaction study to assess the effects of itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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-
- •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
- •Participation in a clinical trial within 30 days prior to the first dose of study drug
- •For Part 2 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.
- •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
- •History of drug allergy to itraconazole or other azole antifungals; history of drug allergy to carbamazepine or carboxamide derivatives [e.g. oxcarbazepine]; known hypersensitivity to drugs structurally related to carbamazepine [e.g.: tricyclic antidepressants] or any of its excipients);history or known hypersensitivity to mefloquine, quinine, or quinidine
研究组 & 干预措施
EDP-235 and Itraconazole interaction (Part 1)
Subjects will receive EDP-235 and Itraconazole on respective dosing days
干预措施: EDP-235 (Drug)
EDP-235 and Itraconazole interaction (Part 1)
Subjects will receive EDP-235 and Itraconazole on respective dosing days
干预措施: Itraconazole (Drug)
EDP-235 and Carbamazepine interaction (Part 2)
Subjects will receive EDP-235 and Carbamazepine on respective dosing days
干预措施: EDP-235 (Drug)
EDP-235 and Carbamazepine interaction (Part 2)
Subjects will receive EDP-235 and Carbamazepine on respective dosing days
干预措施: Carbamazepine (Drug)
EDP and Quinidine interaction (Part 3)
Subjects will receive EDP-235 and Quinidine on respective dosing days
干预措施: EDP-235 (Drug)
EDP and Quinidine interaction (Part 3)
Subjects will receive EDP-235 and Quinidine on respective dosing days
干预措施: Quinidine (Drug)
结局指标
主要结局
Cmax of EDP-235 with and without coadministration with Carbamazepine
时间窗: Day 1 through Day 26
Cmax of EDP-235 with and without coadministration with Quinidine
时间窗: Day 1 through Day 13
Cmax of EDP-235 with and without coadministration with Itraconazole
时间窗: Day 1 through Day 19
AUC of EDP-235 with and without coadministration with Carbamazepine
时间窗: Day 1 through Day 26
AUC of EDP-235 with and without coadministration with Itraconazole
时间窗: Day 1 through Day 19
AUC of EDP-235 with and without coadministration with Quinidine
时间窗: Day 1 through Day 13
次要结局
- Safety measured by adverse events(Up to 34 days)