NCT00909519已完成1 期
A Phase 1, Single-Center, Randomized, Parallel-group, Placebo- and Naproxen- Controlled, Double-blind Study to Evaluate the Effect of Naproxcinod 750 mg Bid Administered for 8 Days on the Renal Hemodynamics, Natriuretic and Renin Responses to a Single Bolus IV Dose of Furosemide 40 mg in Male Healthy Normotensive 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
- 发起方
- NicOx
- 入组人数
- 31
- 主要终点
- To evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo
研究概览
简要总结
This phase 1 study is an 8-day treatment period, randomized, controlled, double-blind, 3 parallel-groups, monocentric study. The primary objective is to evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, non smoker male subjects aged 18 and 35 years (inclusive), at the Screening visit.
- •Body Mass Index (BMI) strictly between 18 and 30 kg/m² (inclusive) with body weight≥ 50 kg at the Screening visit.
- •Normal physical examination at the Screening visit.
- •Normal ECG (12-lead) at the Screening visit, as judged by the Investigator.
- •At Screening and run-in period visits , Systolic Blood Pressure (SBP) between 100 and 139 mmHg (inclusive) and Diastolic Blood Pressure (DBP) between 50 and 89 mmHg (inclusive).
- •At Screening and run-in period visits, HR between 45 and 90 bpm (inclusive).
- •Subjects must be able to understand the written information sheet and informed consent and comply with all study requirements.
- •Subjects must provide a written, dated and signed informed consent prior to any study procedure.
排除标准
- •A history of hypersensitivity reactions (such as asthma, rhinitis, or urticaria) to aspirin, naproxen or any other NSAIDs; or hypersensitivity or contraindications to organic nitrate drugs or hypersensitivity to furosemide or to sinistrine or PAH.
- •Family history of hypertension which may disqualify the subject, as judged by the investigator..
- •History of any clinically relevant gastrointestinal (such as gastritis or gastric ulcer), respiratory, psychiatric, neurologic, kidney, liver, cardiac disease, bleeding disorder, other disease/condition or abnormal physical finding which may interfere with the study objectives. The investigator may disqualify any subject for a sound medical or psychiatric reason.
- •History or presence of ASAT >40UI/L, ALAT >40UI/L, serum bilirubin 3 times above the Upper Limit of Normal range at the Screening visit.
- •Creatinine clearance inferior/equal to 80 ml/min as calculated with the Cockcroft-Gault formula (Appendix 5 of the protocol) at the Screening visit.
- •Plasmatic potassium <3.5 mmole/L at the Screening visit.
- •Seropositivity for HBs, HBc, HIV 1 or HIV 2 at the Screening visit.
- •Donations of blood, plasma or platelets within 3 months prior to the Screening visit or donation planned during the 3 months following Day
- •Any clinically significant abnormal laboratory values at the Screening visit.
- •At the Screening visit, after 1 minute in a standing position, a drop of more than 20 mmHg in SBP or 10 mmHg in DBP or a clinical manifestation of postural hypotension.
- •Chronic use of any drugs (prescription or OTC) within 4 weeks prior to Visit 2 (single use of medication such as paracetamol for headache will be tolerated at the lowest possible dose).
- •Intake of any Nitric Oxide Synthase Inhibitor within 1 month before Screening visit.
- •History of drug addiction or alcohol abuse as defined by DSM IVR, diagnostic criteria for drug and alcohol abuse or drug addiction.
- •Positive drug screening (opiates, cannabinoids, cocaine, benzodiazepines, amphetamines, barbiturates) at the Screening visit.
- •Current participation or participation within 60 days prior to the Screening visit, in another investigational study, including the present study or any previous enrolment in a naproxcinod study.
- •In custody due to an administrative or a legal decision, or under tutelage, or being admitted to a sanitary or social institution.
- •Any direct or indirect involvement with the study conduct or staff at site or any family link with study site staff.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
naproxen
Active Comparator
干预措施: Naproxen (Drug)
naproxcinod
Experimental
干预措施: naproxcinod (Drug)
naproxcinod
Experimental
干预措施: furosemide (Drug)
结局指标
主要结局
To evaluate the effect of naproxcinod on the renal function when co-administered with furosemide in comparison to naproxen and placebo
时间窗: Day 8, between H3 and H9
次要结局
- to assess the effect of naproxcinod on blood pressure (BP) in comparison with naproxen and placebo over 1 week and when co-administered with furosemide + to assess the general safety and tolerability(for over 1 week)
- To evaluate the effect of naproxcinod when administered alone on renal function, after a week of administration, in comparison with naproxen and placebo.(Day 8 at H4)
研究者
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