A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Leritrelvir(RAY1216)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir(RAY1216)
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be ≥ 18 to ≤ 70 years, at the time of signing the informed consent.
- •BMI ≥ 18 kg/m2 up to ≤ 32 kg/m
- •Participants (including partners) must use reliable methods of contraception during the study and until 7 days following the last dose of investigational product.
- •Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.
- •Participants with hepatic impairment only:
- •Supporting documents confirming that the participant has liver cirrhosis with hepatic impairment must be available.
- •Unless otherwise stated, participants must have been on stable doses and regimens of the concomitant medication for at least 4 weeks before screening, or treatment-naïve participants
排除标准
- •Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
- •QTcF (male) > 470ms，QTcF (female) > 480ms
- •Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
- •Participates who donated blood or bleeding profusely (> 400 mL) in the 3 months.
- •Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
- •Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening
- •Participants with Normal Hepatic Function Only:
- •Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.
- •Participants with Hepatic Impairment Only:
- •Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders.
- •Participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices
研究组 & 干预措施
Child-Pugh A
8 participants with mild hepatic impairment (Child-Pugh A) will be given 400mg of Leritrelvir(RAY1216)
干预措施: Leritrelvir(Ray1216) (Drug)
Child-Pugh B
8 participants with mild hepatic impairment (Child-Pugh B) will be given 400mg of Leritrelvir(RAY1216)
干预措施: Leritrelvir(Ray1216) (Drug)
Normal hepatic function
8 participants with normal hepatic function will be given 400mg of Leritrelvir(RAY1216)
干预措施: Leritrelvir(Ray1216) (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Day 1 to Day 4
The Cmax of a single dose of Leritrelvir in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Area under the concentration-time curve from time zero to infinity (AUCinf)
时间窗: Day 1 to Day 4
The AUCinf of a single dose of Leritrelvir in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)
时间窗: Day 1 to Day 4
The AUClast of a single dose of Leritrelvir in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
次要结局
- Number of participants with drug-related adverse events as assessed by CTCAE v5.0(Day 1 to Day 7)