A Phase 1, Open-label, Fixed-sequence Study to Estimate the Effects of Multiple-dose Administration of Itraconazole on the Pharmacokinetics of SHR8554 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Tmax：observed time to reach Cmax
研究概览
简要总结
This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects, aged 18 to 45 years (inclusive).
- •Female subjects body weight≥45 kg, male subjects body weight≥50 kg, body mass index (BMI) of 19.0 to 26.0 kg/m2 (inclusive).
- •Understand the study procedures in the informed consent form and be willing and able to comply with the protocol.
排除标准
- •Subjects with a history of drug allergy, or a history of specific allergies, or known allergy to SHR8554 or itraconazole or similar.
- •Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study as determined by the investigator.
- •Subjects with positive tests for infectious diseases.
- •Subjects who have undergone major surgery within 3 months prior to screening or have undergone surgery that could significantly affect the in vivo course or safety evaluation of the study drug.
- •History of using any medication within 2 weeks prior to the first dosing.
- •Subjects who have received vaccination within 1 month prior to screening or plan to receive vaccination during the trial.
- •Excessive daily consumption of tea, coffee, grapefruit/grapefruit juice and other special diets in the 1 month prior to screening.
- •Subjects with a history of substance abuse, drug use or a positive screening test for substance abuse.
- •Female who are pregnant or breastfeeding, or have a positive pregnancy test.
- •Subjects who may not be able to complete the study for other reasons or who the investigator believes should not be included.
研究组 & 干预措施
SHR8554 and itraconazole
SHR8554 will be provided in a solution. Participants will receive 1 mg SHR8554 by intravenous pump on Day 1 and Day 9.
Itraconazole capsules 200 mg orally after meals twice daily for 7 days from Day 4 to Day 10.
干预措施: SHR8554；Itraconazole (Drug)
结局指标
主要结局
Tmax：observed time to reach Cmax
时间窗: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Cmax：observed maximum plasma concentration
时间窗: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
AUC0-∞：area under the plasma concentration-time curve from time 0 to infinity
时间窗: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Vz ：apparent volume of distribution
时间窗: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
时间窗: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
MRT0-∞：mean residence time from time 0 to infinity
时间窗: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
次要结局
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(Baseline up to Day 18)
- Incidence of participants with clinical laboratory abnormalities(Baseline up to Day 18)
- Incidence of participants with vital signs abnormalities(Baseline up to Day 18)
- Incidence of participants with physical exam abnormalities(Baseline up to Day 18)