NCT07007806已完成1 期
A Phase 1, Open-Label, Single-Sequence Study to Assess the Effect of Multiple Doses of Omeprazole on the Single-Dose Pharmacokinetics of Bemnifosbuvir/Ruzasvir Fixed-Dose Combination in Healthy Adult 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
- 20
- 试验地点
- 1
- 主要终点
- PK of BEM/RZR
研究概览
简要总结
Drug-drug interaction study between Omeprazole and Bemnifosbuvir/Ruzasvir (BEM/RZR)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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 acceptable contraceptive methods through at least 90 days after the last dose of study drug.
- •Minimum body weight of 50 kg and body mass index (BMI) of 18.5-30 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
Arm (n=20)
Experimental
干预措施: Treatment B-Omeprazole 20 mg dose administered fasting (Drug)
Arm (n=20)
Experimental
干预措施: Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fasting (Drug)
Arm (n=20)
Experimental
干预措施: Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fasting (Drug)
Arm (n=20)
Experimental
干预措施: Treatment D-Bemnifosbuvir/Ruzasvir FDC administered 0.5 hour prior to 20 mg dose of Omeprazole (Drug)
Arm (n=20)
Experimental
干预措施: Treatment E-Omeprazole 40 mg administered fasting (Drug)
Arm (n=20)
Experimental
干预措施: Treatment F-Bemnifosbuvir/Ruzasvir FDC administered 2 hours after 40 mg dose Omeprazole (Drug)
结局指标
主要结局
PK of BEM/RZR
时间窗: Day 1, 7, 8, 13, 18
AUC
PK of Omeprazole
时间窗: Day 7, 8
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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