ACTRN12620001048976招募中1 期
A Phase 1 Open-Label, Parallel-Group, Single-Dose Study toEvaluate the Pharmacokinetics of Remdesivir and Metabolites inParticipants with Normal Renal Function and Renal Impairment
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
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
入排标准
- 年龄范围
- 18 Years 至 79 Years（—）
- 性别
- All
入选标准
- •Have the ability to understand and sign a written informed consent form (ICF), which must
- •be obtained prior to initiation of study procedures
- •Have a calculated BMI of BMI 18 to 38 kg/m2 at screening
- •Participants with renal impairment must also meet the following additional inclusion criteria to
- •be eligible for participation in this study:
- •Have renal impairment classification at screening that has been unchanged during the
- •3 months prior to screening
- •eGFR must be the following (using the MDRD equation) based on serum creatinine (Scr) as
- •measured at the screening evaluation:
- •Mild Renal Impairment: eGFRMDRD 60-89 mL/min/1.73m2
- •Moderate Renal Impairment: eGFRMDRD 30-59 mL/min/1.73m2
- •Severe Renal Impairment: eGFRMDRD < 30 mL/min/1.73m2
- •ESRD: eGFRMDRD < 15 mL/min/1.73m2 on chronic HD
排除标准
- •Positive serum pregnancy test
- •Lactating female
- •Any prior exposure to RDV, unless allowed by the sponsor
- •Have current alcohol or substance abuse judged by the investigator to potentially interfere
- •with participant compliance or participant safety, or a positive drug or alcohol test at
- •screening or baseline
- •Have a positive test result for human immunodeficiency virus type 1 (HIV-1)/human
- •immunodeficiency virus type 2 (HIV-2) antibody, hepatitis B surface antigen, or hepatitis C
- •virus (HCV) antibody with concurrent positive viral load at screening
- •Have poor venous access that limits phlebotomy
研究者
相似试验
进行中（未招募）
1 期
Study in Participants With Normal Kidney Function and Reduced Kidney Function to Test How Kidney Function Can Change What Happens to Obeldesivir in the BodyCTIS2023-504780-17-00Gilead Sciences Inc.60
已完成
不适用
A Phase 1, single-dose, open-label, parallel group study to assess the relative bioavailability of simeprevir, odalasvir and AL-335 when administered in different fixed-dose combination formulations compared to the single agents when administered together, in healthy subjects10047438Hepatitus CNL-OMON43128Janssen-Cilag108
进行中（未招募）
1 期
A study of an oral anticoagulant (Edoxaban) in childreEUCTR2015-005732-18-ITDaiichi Sankyo , Inc.66
进行中（未招募）
1 期
A study of an oral anticoagulant (Edoxaban) in childrePatients who are at risk of thromboembolic events (e.g., patients with thrombophilia, congenital heart disease, presence of a central venous catheter)Patients with cardiac conditions who may need anticoagulation therapyor Patients with sickle cell disease who may need anticoagulation therapy.MedDRA version: 19.0 Level: LLT Classification code 10010495 Term: Congenital heart disease NOS System Organ Class: 100000004850MedDRA version: 19.0 Level: LLT Classification code 10057396 Term: Thrombophilia System Organ Class: 100000004851EUCTR2015-005732-18-FRDaiichi Sankyo , Inc.48
进行中（未招募）
1 期
A study of an oral anticoagulant (Edoxaban) in childreEdoxaban is being investigated for use in pediatric patients who may require anticoagulation therapy.MedDRA version: 19.0Level: LLTClassification code 10010495Term: Congenital heart disease NOSSystem Organ Class: 100000004850MedDRA version: 19.0Level: LLTClassification code 10057396Term: ThrombophiliaSystem Organ Class: 100000004851EUCTR2015-005732-18-ESDaiichi Sankyo , Inc.66