A Single-center, Open-label and Sequential-dosing Clinical Trial Investigating the Drug Interaction Between ADC-189 Tablet and Itraconazole Capsule in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUC[0-∞] of ADC-189
研究概览
简要总结
This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of ADC189 in healthy adults.
Participants in this study will complete screening assessments within 14 days before the first dose of ADC189. Participants will be admitted to the clinical pharmacology center (CPC) and complete 2 periods of treatments. On Day 1 and 26, each participant will receive a single oral dose of ADC189 (45mg), under fasting condition On Day 22, all participants will receive oral doses of itraconazole 200 mg (bid), after meal. From Day 23 to Day 25, and Day 26-D39, participants will receive itraconazole 200 mg(qd). Blood and safety assessments will continue for 336-hours after dosing on Day 1 and Day 26. Participants will receive a telephone follow-up on D47 (±3) days for a final visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Sign informed consent, be capable of and willing to comply with study restrictions and procedures.
- •Healthy adult subjects aged 18 to 55 years.
- •Weight >=50kg for males, and >=45kg for females, BMI 19-26 kg/m^
- •No clinical significance in physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal ultrasound, and chest X-ray examination.
排除标准
- •Subjects who participated in other drug trials within 3 months before screening
- •Hospital admission or major surgery within 4 weeks prior to screening or a preplanned hospital admission during study participation
- •Donated or lost ≥400 mL of blood in the previous 3 months before screening
- •Have a history of allergic diseases (asthma, urticaria, eczema, etc.), or food allergies
- •A history of drug abuse in the past five years
- •Any condition or finding that in the Investigator's opinion would put the participant or study conduct at risk if the participant were to participate in the study
- •Unable to complete this study for other reasons or the Investigator believes that he or she should be excluded
研究组 & 干预措施
ADC-189 and itraconazole
Part 1: Single dose of ADC-189
Part 2: Itraconazole with single dose of ADC-189
干预措施: ADC-189 and Itraconazole (Drug)
结局指标
主要结局
AUC[0-∞] of ADC-189
时间窗: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
Pharmacokinetics (PK) parameter: Area under the curve from time 0 hour to ∞
Cmax of ADC-189
时间窗: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
PK parameter: Maximum observed concentration
AUC[0-t] of ADC-189
时间窗: Part 1: Day 1 to Day 15; Part 2: Day 21 to Day 40
PK parameter: Area under the curve from time 0 to 336 hour
Adverse events (AEs)
时间窗: Day 1 to Day 43
Number of subjects reporting AEs
次要结局
未报告次要终点