ACTRN12617000822381已完成1 期
A Phase I, Single-Dose, Open-Label Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of APL-2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •All Subjects:
- •1.Body mass index (BMI) greater than or equal to 18.5 and less than or equal to 36.0 kg/m2
- •2.Willingness to utilize an approved form of contraception
- •Cohort 1 (Severe Renal Impaired Subjects):
- •1.Screening CLCR <30 mL/min
- •2.Supine blood pressure less than or equal to 190/105 mmHg
- •3.Stable renal function
- •Cohort 2 (Matched Control Group):
- •1..Screening CLCR greater than or equal to 60 mL/min
- •2.Supine blood pressure less than or equal to 160/95 mmHg
- •Each subject in Cohort 2 will be matched with an individual subject in Cohort 1.
排除标准
- •1.Acute renal failure.
- •2.History of renal transplant
- •3.Dialysis or hemofiltration
- •4.Clinically significant disease or illness (other than renal impairment)
- •5.Febrile illness/infection within 21 days prior to dosing
- •6.Human immunodeficiency virus; hepatitis B virus, and/or hepatitis C virus
- •7.Pregnancy, or lactating/breastfeeding
研究者
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