ACTRN12616000389404已完成1 期
A Study to Evaluate the Pharmacokinetics (PK) and Safety of DUR-928 in Subjects with Impaired Kidney Function and Matched Control Subjects with Normal Kidney Function
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
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 75 Years（—）
- 性别
- All
入选标准
- •All participants:
- •Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed
- •Female subjects must be of non-childbearing potential
- •Willing and be able to be admitted to the clinical study unit for 3 nights and 3 days
- •Able to abstain from alcohol and tobacco use during the study
- •Patient with impaired kidney function:
- •Impaired kidney function at screening, defined as Stage 3 kidney disease (eGFR between 30 and 59 ml/min/1.73m2) and stage 4 kidney disease (eGFR between 15 and 29 ml/min/1.73m2)
- •Existing diagnosis of chronic kidney disease
- •Matching healthy control subjects:
- •Healthy as determined by medical history, physical examination, laboratory tests, ECG and vital signs in consideration of the individual’s age
排除标准
- •All participants:
- •Females of child-bearing potential; pregnant or breastfeeding
- •Significant blood loss, donated blood or received medication in another clinical trial 30 days prior to study participation
- •Be immunocompromised (including history/seropositive of HIV)
- •Be receiving any pharmacological treatment which might alter the absorption or metabolism of drugs
- •Have a history of febrile illness 5 days prior to dosing
- •Positive drug of abuse or alcohol breath test
- •History of malignancy within 5 years before screening (except squamous and basal cell carcinomas of the skin and carcinomas of the cervix in situ, or a malignancy that in the opinion of the study physician and the medical monitor as cured with minimal risk of recurrence
- •History of maintenance dialysis or kidney transplant
- •History or presence of clinically concerning arrhythmias or prolongation of screening QT or QTc intervals
- •Patient with impaired kidney disease:
- •History of clinically significant comorbidity that increases the risk of adverse events
- •Have any surgical or medical condition (other than impaired kidney disease) which might significantly alter the absorption or metabolism of drugs or which may jeopardies the subject during participation
- •Presence of impaired liver function
- •Clinical evidence of active liver disease, liver cirrhosis or severe ascites requiring intervention
- •Symptoms or history of hepatic encephalopathy within 4 weeks of study entry
- •Evidence of progressive kidney disease or unstable kidney function in the view of the investigator
- •Matching healthy control subjects:
- •Evidence of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurologic, or allergic disease (excluding well treated, asymptomatic seasonal allergies)
- •Have any surgical or medical condition which might significantly alter the absorption or metabolism of drugs or which may jeopardies the subject during participation
- •Presence of impaired liver function
- •Clinical evidence of kidney disease or kidney injury
研究者
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