NCT05731843已完成1 期
A Phase 1, Open-Label Study to Evaluate the Potential Drug-Drug Interaction Between Bemnifosbuvir and Ruzasvir and Food-Drug Interaction in Healthy Adult Subjects
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
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK) of BEM
研究概览
简要总结
Drug-drug interaction study of Ruzasvir and Bemnifosbuvir
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 55 Years（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.
- •Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m
- •Willing to comply with the study requirements and to provide written informed consent.
排除标准
- •Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-
- •Abuse of alcohol or drugs.
- •Use of other investigational drugs within 28 days of dosing.
- •Concomitant use of prescription medications, or systemic over-the-counter medications.
- •Other clinically significant medical conditions or laboratory abnormalities.
研究组 & 干预措施
BEM vs BEM + Ruzasvir n=16
Experimental
干预措施: Cohort 1 BEM + Ruzasvir (Drug)
Ruzasvir vs Ruzasvir + BEM n=16
Experimental
干预措施: Cohort 2 Ruzasvir + BEM (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of BEM
时间窗: Days 6, 12, 18
Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)
Pharmacokinetics (PK) of Ruzasvir
时间窗: Days 6, 12, 18
Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC)
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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