NCT02992236已完成1 期
Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Renal Plasma Flow
研究概览
简要总结
Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on renal function and perfusion in 16 healthy subjects.
详细描述
Analysis of the effect of i.v. VAS203 on renal function and perfusion in healthy subjects.
Primary objective:
Possible adverse effect of VAS203 on the Renal Plasma Flow (RPF) and the Glomerular Filtration Rate (GFR) during and after 6 hours of constant-rate iv. infusion of 10 mg/kg VAS203.
Secondary objective:
To analyse the effects of VAS203 on
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Informed consent in writing available.
- •Willing and able to comply with all requirements of the study.
- •Male, 18 and 45 years (inclusive).
- •Subject has a body weight between 60 kg and 100 kg, extremes included.
- •BMI 18 to 27 kg/m
- •Serum creatinine within reference range (≤1.2 mg/dL) and Cockroft-Gault Clearance > 90 ml/min
- •Good general health as judged by the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure and pulse rate) and clinical laboratory parameters (clinical chemistry, hematology, and urinalysis)
排除标准
- •Clinically significant abnormalities in physical examination, vital signs or clinical laboratory parameters (according to the Investigator's judgment).
- •Serum glutamate oxaloacetate transaminase or glutamate-pyruvate transaminase > 2-times above the upper limit of normal range.
- •Subject with Cockcroft-Gault clearance < 90 ml/min.
- •Clinically significant history of cardiovascular disease or any known present cardiovascular disease.
- •History of clinically significant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders.
- •Office blood pressure at screening higher than 160/100 mmHg, or lower than 95/55 mmHg.
- •Office heart rate at screening after at least 5 minutes outside the range of 50- 99 beats per minute (inclusive).
- •Concomitant use of OTC medication within 1 week prior to dosing, except use of paracetamol (up to 2 g/day).
- •Participation in any other clinical study within 30 days prior to inclusion in this -
研究组 & 干预措施
Placebo
Placebo Comparator
Infusion (6 hours) of Saline
干预措施: Saline (Drug)
VAS203
Active Comparator
Infusion (6 hours) of VAS203 (10 mg/kg)
干预措施: VAS203 (Drug)
结局指标
主要结局
Renal Plasma Flow
时间窗: 0, 2h, 4h, 6h and 8 h after start of infusion
Renal plasma flow measurement by para-Amino-Hippuric-Acid Clearance Method
Glomerular Filtration Rate
时间窗: 0, 2h, 4h, 6h and 8 h after start of infusion
by para-Amino-Hippuric Acid Clearance Method
次要结局
- Serum Creatinine Concentration(0, 2h, 4h, 6h, 8h, 10h, 24h and 48h after start of infusion)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effects of Vasodilators on Renal Function and Neuroholmonal Activation in Patients With Acute Pulmonary EdemaAcute Cardiogenic Pulmonary EdemaJPRN-UMIN000002905Cardiovascular Division, Hyogo College of Medicine60
进行中（未招募）
1 期
Vasopressiinin vaikutus munuaisten toimintaan sydänleikkauksen jälkeisessä vasodilatoivassa shokissasydänleikkauspotilaita, joilla on perfuusion jälkeinen vasodilatoiva shokkiMedDRA version: 9.1 Level: LLT Classification code 10048348 Term: Hypotension aggravatedEUCTR2007-001816-22-FIAnne Ristikankare40
已完成
2 期
Effect of vasopressin and norepinephrine on Renal function of patients undergoing CABG in Emam Khomeini hospital of ArdabilOpen heart sergury.Ischaemic heart diseasesI20-25IRCT201412054256N4Ardabil University of Medical Sciences120
进行中（未招募）
不适用
The effect of sodium nitrite on kidney salt and water regulation, blood pressure regulating hormones and blood pressure in healthy subjects during inhibition of various enzyme systems.The normal physiological responses in healthy subjectsMedDRA version: 14.1Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - InvestigationsEUCTR2013-003404-39-DKDepartment of Medical Research, Regional Hospital Holstebro
已完成
不适用
Evaluation of renal effect of NSAIDhealth volunteerJPRN-UMIN000002278kawasaki medical school20