NCT05724693已完成1 期
A Phase 1, Multicenter, Open-Label, Parallel-Group, Pharmacokinetic Single Dose Study of Bemnifosbuvir (AT-527) in Adult Subjects With Normal and Impaired Hepatic Function
适应症
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
- 39
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK) of BEM AUC
研究概览
简要总结
To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir 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 42.0 kg/m2
- •Willing to comply with the study requirements and to provide written informed consent
- •Subjects with Normal Hepatic Function (Groups 3 and 5):
- •Medically healthy, in the opinion of an Investigator
- •Must match by gender, age (± 10 years), and BMI (± 20%) to the pooled mean values of subjects with hepatic impairment
- •Hepatic Impaired Subjects (Groups 1, 2, and 4):
- •Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
- •When applicable, presence of mild hepatic impairment (Child-Pugh Class A: score of 5 to 6), moderate hepatic impairment (Child-Pugh Class B: score of 7 to 9) or severe hepatic impairment (Child-Pugh Class C: score of 10 to 15). Hepatic impairment should be stable for at least 1 month prior to Screening
排除标准
- •Pregnant or breastfeeding
- •Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
- •Abuse of alcohol or drugs
- •Use of other investigational drugs within 28 days of dosing
- •Other clinically significant medical conditions or laboratory abnormalities
- •Hepatic Impaired Subjects (Groups 1, 2, and 4):
- •Currently undergoing any method of dialysis
- •History of liver transplant
- •Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) > 10%
- •Evidence of hepatic carcinoma presence at Screening
研究组 & 干预措施
Group 1 -Mild Hepatic Impairment
Experimental
Drug: single dose Bemnifosbuvir (BEM)
干预措施: Bemnifosbuvir (BEM) (Drug)
Group 2-Moderate Hepatic Impairment
Experimental
Drug: single dose Bemnifosbuvir (BEM)
干预措施: Bemnifosbuvir (BEM) (Drug)
Group 3 - Healthy Subjects matching mild and moderate impairment groups
Experimental
Drug: single dose Bemnifosbuvir (BEM)
干预措施: Bemnifosbuvir (BEM) (Drug)
Group 4 - Severe Hepatic Impairment
Experimental
Drug: single dose Bemnifosbuvir (BEM)
干预措施: Bemnifosbuvir (BEM) (Drug)
Group 5 - Normal hepatic function matching severe impairment group
Experimental
Drug: single dose Bemnifosbuvir (BEM)
干预措施: Bemnifosbuvir (BEM) (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of BEM AUC
时间窗: Day 1
Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)
时间窗: Day 1
Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)
时间窗: Day 1
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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