NCT04784000已完成1 期
A Phase 1 Study Assessing the Effect of Carbamazepine, a P-Glycoprotein Inducer, on the Pharmacokinetics of AT-527 in Healthy Adult Subjects
适应症
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
- Pharmacokinetics (PK) of AT-527 (RO7496998)
研究概览
简要总结
This study will determine the effect of carbamazepine on the PK of AT-527 (RO7496998) 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
- None
入排标准
- 年龄范围
- 18 Years 至 65 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
- •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
- •Use of other prescription drugs with 28 days of dosing
- •Other clinically significant medical conditions or laboratory abnormalities
结局指标
主要结局
Pharmacokinetics (PK) of AT-527 (RO7496998)
时间窗: Day 1 vs Day 26
Maximum plasma concentration (Cmax)
次要结局
未报告次要终点
研究者
研究点 (1)
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