临床试验/NCT04849299

NCT04849299已完成1 期

A Phase 1, Randomized, Open-Label Study to Evaluate the Effect of Cyclosporine on the Plasma Pharmacokinetics of AT-527 in Healthy Adult Male Subjects

Atea Pharmaceuticals, Inc.1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2021年4月18日最近更新: 2021年8月2日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Atea Pharmaceuticals, Inc.
入组人数: 24
试验地点: 1
主要终点: Pharmacokinetics (PK) of AT-527 (R07496998): AUC

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will determine the effect of cyclosporine on the PK of AT-527 (R07496998) in healthy male subjects

研究设计

研究类型: Interventional
分配方式: 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: Male
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/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-527 550 mg + cyclosporine (simultaneous)

Experimental

n=12

干预措施: AT-527 550 mg + cyclosporine (Drug)

AT-527 550 mg + cyclosporine (staggered)

Experimental

n=12

干预措施: AT-527 550 mg + cyclosporine (Drug)

结局指标

主要结局

Pharmacokinetics (PK) of AT-527 (R07496998): AUC

时间窗: Day 1 vs Day 7

Area under the concentration-time curve (AUC)

Pharmacokinetics (PK) of AT-527 (R07496998): Cmax

时间窗: Day 1 vs Day 7

Maximum plasma concentration (Cmax)

次要结局

未报告次要终点

研究者

发起方

Atea Pharmaceuticals, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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