NCT05618314已完成1 期
A Phase 1, Open-Label, Parallel-Group, Single-Dose Adaptive Study to Evaluate the Safety and Pharmacokinetics of AT-527 in Adult Subjects With Normal and Impaired Renal Function Sub-Study: Effects of Probenecid on the Pharmacokinetics of AT-527 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
- 36
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax)
研究概览
简要总结
Study of AT-527 in Subjects with Normal and Impaired Renal Function
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 80 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
- •BMI of 18.5 to 42.0 kg/m2
- •Willing to comply with the study requirements and to provide written informed consent
- •Subjects with Normal Renal Function (Group E):
- •Medically healthy, in the opinion of an Investigator
- •Normal renal function with eGFR ≥ 90 mL/min/1.73m2 at Screening
- •Renal Impaired Subjects (Groups A, B, and C):
- •Considered stable in the judgement of an Investigator
- •Presence of severe renal impairment (eGFR ≥ 15 and < 30 mL/min/1.73m2), moderate renal impairment (eGFR ≥ 30 and < 60 mL/min/1.73m2) or mild renal impairment (eGFR ≥ 60 and < 90 mL/min/1.73m2) at Screening: renal impairment should have been stable for at least 1 month prior to Screening.
- •Subjects with End-Stage Renal Disease -ESRD (Group D)
- •Considered clinically stable in the opinion of the Investigator
- •Presence of ESRD (eGFR <15 mL/min/1.73m2 and being on intermittent hemodialysis) at Screening and have been stable for at least 1 month prior to Screening
排除标准
- •Pregnant or breastfeeding
- •Infected with 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
- •Subjects with Normal Renal Function (Group E):
- •Any clinically significant illness in the opinion of the investigator
- •Subjects with Impaired Renal Function (Group A, B, C and D):
- •History of renal transplant
- •Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) > 10%
- •Subjects requiring treatment for renal impairment or other chronic disease must be on a stable treatment plan
研究组 & 干预措施
Group C-Severe Renal Impairment (optional)
Experimental
single dose AT-527
干预措施: AT-527 (Drug)
Group A-Mild Renal Impairment
Experimental
single dose AT-527
干预措施: AT-527 (Drug)
Group B-Moderate Renal Impairment
Experimental
single dose AT-527
干预措施: AT-527 (Drug)
Group D-End-Stage Renal Disease (optional)
Experimental
single dose of AT-527 pre- and post-dialysis
干预措施: AT-527 (Drug)
Group E-Matched Healthy Subjects
Experimental
Single dose of AT-527 on Days 1 and 15. Probenecid administered twice daily (BID) Days 14-19
干预措施: AT-527 and Probenecid (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of AT-527 Maximum plasma concentration (Cmax)
时间窗: Day 1
Pharmacokinetics (PK) of AT-527 Area under the plasma concentration-time curve (AUC)
时间窗: Day 1
Pharmacokinetics (PK) of AT-527 AUC
时间窗: Day 1
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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