NCT06911320已完成1 期
A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of Bemnifosbuvir and Ruzasvir Administered as a Fixed-Dose Combination in Adult Participants With Severe Renal or Hepatic Impairment in Comparison to Healthy Participants
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax)
研究概览
简要总结
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
- •Females must have a negative pregnancy test at Screening and prior to dosing
- •BMI of 18.5 to 43.0 kg/m2
- •Willing to comply with the study requirements and to provide written informed consent
- •Renal Impaired Subjects (Group 1):
- •Considered stable in the judgement of an Investigator
- •Presence of severe renal impairment or kidney failure (as defined by eGFR< 30 mL/ min)
- •Hepatic Impaired Subjects (Group 2):
- •Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
- •Presence of severe hepatic impairment (Child-Pugh Class C: score of 10 to 15).
- •Subjects with Normal Hepatic and Renal Function (Group 3):
- •Medically healthy, in the opinion of an Investigator
- •Must match by gender, age (± 10 years), and BMI (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment
排除标准
- •Pregnant or breastfeeding
- •Infected with hepatitis B virus, hepatitis C virus or HIV
- •Abuse of alcohol or drugs
- •Use of other investigational drugs within 28 days of dosing
- •Other clinically significant medical conditions or laboratory abnormalities
- •Renal and Hepatic Impaired Subjects (Group 1 and 2):
- •Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c > 10%
- •Undergoing any method of dialysis
- •Subjects requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan
- •Renal Impaired Subjects (Group 1):
- •History of renal transplant
- •Concurrent use of medications known to affect the elimination of serum creatinine
- •Hepatic Impaired Subjects (Group 2):
- •History of liver transplant
- •Evidence of hepatic carcinoma presence at Screening
研究组 & 干预措施
Group 1 - Severe Renal Impairment
Experimental
Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
干预措施: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination (Drug)
Group 2 - Severe Hepatic Impairment
Experimental
Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
干预措施: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination (Drug)
Group 3 - Matched Healthy Subjects
Experimental
Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
干预措施: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax)
时间窗: Day 1
Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC)
时间窗: Day 1
Pharmacokinetics (PK) of BEM/RZR AUC
时间窗: Day 1
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
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