NCT05154123已完成1 期
A Phase 1, Open-Label Study to Evaluate the Effect of AT-527 on the Pharmacokinetics of Rosuvastatin in Healthy Adult Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- To determine the effect of a staggered dose of AT-527 administered 2 hours before rosuvastatin on the PK of rosuvastatin
研究概览
简要总结
Drug-drug interaction study of rosuvastatin and AT-527 (R07496998)
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 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
- •Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
- •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
AT-527 + rosuvastatin (staggered) n=14
Experimental
干预措施: AT-527 + rosuvastatin (Drug)
结局指标
主要结局
To determine the effect of a staggered dose of AT-527 administered 2 hours before rosuvastatin on the PK of rosuvastatin
时间窗: Day 1, Day 8
Maximum plasma concentration (Cmax)
To evaluate the effect of co-administration of AT-527 on the single-dose pharmacokinetics (PK) of rosuvastatin
时间窗: Day 1, Day 8
Area under the 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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