A Phase I, Open-Label, Parallel-Group, Multiple-Dose Study to Determine the Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment and in Healthy Control Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Cmax of favipiravir
研究概览
简要总结
This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hepatically impaired groups:
- •Agree to doctor approved birth control methods from Day 1 until 3 months following the final dose of study drug.
- •Have mild hepatic impairment (Child-Pugh Clinical Assessment Score Grade A, score 5 6) or moderate hepatic impairment (Child-Pugh Clinical Assessment Score Grade B, score 7-9) or severe hepatic impairment (Child-Pugh Clinical Assessment Score Grade C, score 10-15);
- •Control group
- •Agree to doctor approved birth control methods from Day 1 until 3 months following the final dose of study drug.
- •Healthy as determined by medical history, physical exam, vital signs, ECGs, and clinical laboratory tests.
排除标准
- •Hepatically impaired groups:
- •Have used any drugs known to significantly affect hepatic metabolism within 28 days, or is unable or unwilling to forgo the use of such products throughout the study;
- •Have any acute or unstable condition or disease, other than impaired hepatic function, as determined by medical history, physical exam, ECG and clinical laboratory tests;
- •Known ongoing alcohol and/or drug abuse within 1 month
- •Any evidence of progressive worsening liver function disease as indicated by laboratory values;
- •Have had an acute flare of hepatitis A or B within 6 months;
- •Have acute, fulminant alcoholic hepatitis, determined either clinically or by histology;
- •Have a history of hepatoma or metastatic disease of the liver;
- •Control group:
- •Have used any drugs known to significantly affect hepatic metabolism within 28 days, or is unable or unwilling to forgo the use of such products throughout the study;
- •Have a history or presence of clinically cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic, oncologic, psychiatric, pulmonary, or renal disease or any other condition.
研究组 & 干预措施
Group 2
Mild hepatic impairment
干预措施: Favipiravir (Drug)
Group 3
Moderate hepatic impairment
干预措施: Favipiravir (Drug)
Group 1
Normal hepatic function
干预措施: Favipiravir (Drug)
Group 4
Severe hepatic impairment
干预措施: Favipiravir (Drug)
结局指标
主要结局
Cmax of favipiravir
时间窗: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 18, 24, 36, 48 hours post-dose on Day 1 and Day 5
The PK parameters for favipiravir and its metabolite in hepatically impaired adult subjects relative to healthy adult subjects matched for age, weight, gender, and race status on Day 1 and on Day 5.
AUC of favipiravir
时间窗: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 18, 24, 36, 48 hours post-dose on Day 1 and Day 5
The PK parameters for favipiravir and its metabolite in hepatically impaired adult subjects relative to healthy adult subjects matched for age, weight, gender, and race status on Day 1 and on Day 5.
次要结局
- vital signs(13 days)
- electrocardiograms [ECGs](13 days)
- clinical laboratory assessment(13 days)
- adverse events [AEs](13 days)
- physical examination(13 days)