NCT05905484已完成1 期
A Phase 1, Double-blind, Single-dose, Randomized, Placebo and Active-Controlled, Four-Way Crossover Study Evaluating the Effects of Bemnifosbuvir on Cardiac Repolarization 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
- 35
- 试验地点
- 1
- 主要终点
- Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc).
研究概览
简要总结
This study will assess the effects of Bemnifosbuvir on cardiac repolarization in healthy Adult Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Females must have a negative pregnancy test at Screening and prior to dosing
- •Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
- •Willing to comply with the study requirements and to provide written informed consent
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
研究组 & 干预措施
Bemnifosbuvir (BEM) therapeutic dose
Experimental
oral tablets
干预措施: Bemnifosbuvir (BEM) (Drug)
Bemnifosbuvir (BEM) supratherapeutic dose
Experimental
oral tablets
干预措施: Bemnifosbuvir (BEM) (Drug)
Placebo
Placebo Comparator
oral tablets
干预措施: Placebo (Drug)
Moxifloxacin
Active Comparator
oral tablet
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Placebo-corrected (Δ) change-from-baseline QTc (ΔΔQTc).
时间窗: 24 hours prior to dosing thru 48 hours post dose
C-QTc analysis
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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