NCT02110459已完成1 期
An Open-label, Non-randomized, Monocenter, Single-dose, Phase I Study to Evaluate Pharmacokinetics and Safety of POL7080 Administered as Single Intravenous Infusion to Subjects With Renal Impairment
Polyphor Ltd.1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2013年4月最近更新:
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
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To measure the plasma concentrations of POL7080
研究概览
简要总结
To investigate the pharmacokinetics (PK) of POL7080 in subjects with renal function impairment after single intravenous (IV) infusion of POL7080
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who signed informed consent.
- •Male subjects ≥18 and ≤79 years of age; female subjects ≥18 and ≤79 years of age of non-childbearing potential
- •Weight within a BMI range of 19.0-35.0 kg/m
- •CLCr according to Cockcroft Gault equation of:
- •50-80 mL/min (mild renal impairment)
- •30- <50 mL/min (moderate renal impairment)
- •<30 mL/min (severe renal impairment)
- •subjects receiving dialysis for ≥3 months before dosing (ESRD)
- •>80 mL/min (normal renal function)
排除标准
- •Unwilling or unable to give informed consent.
- •As a result of the medical screening process, the study physician considers the subject unfit for the study.
- •Demonstrating excess in xanthine consumption (more than 5 cups of coffee or equivalent per day).
- •Subjects who smoke more than 10 cigarettes a day.
- •Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week.
- •Any history of hypersensitivity to the IMP.
- •For subjects with renal impairment: No clinically significant change in disease status within at least 1 month prior to study entry, as determined by the investigator.
- •The subject had donated a unit of blood (450 mL) within the 3 months before dosing, or intends to donate in the month after the last scheduled visit.
- •Participation in another clinical study with an investigational drug or device within the last month.
- •Subjects with clinically significant telemetric ECG abnormalities on Day -1
- •Significant allergies requiring intranasal or systemic corticosteroids during any time of the year or history of any anaphylactic reaction.
- •Positive test for human immunodeficiency virus (HIV) antibodies.
- •Acute Hepatitis B or C infection.
- •The subject has tested positive for drugs of abuse at screening.
- •Subjects who have received any prescribed systemic or topical medication within 4 weeks prior to dosing (excluded are those drugs the renally impaired subject is currently taking for treatment of the renal or concomitant disease).
- •Immunocompromised patients (patients after solid organ or bone marrow transplant; patients receiving immunosuppressive treatment).
- •Subjects with known or suspected Pseudomonas infection or colonization (e.g. patients with cystic fibrosis).
- •Subjects with significant liver function abnormalities
- •Subjects with acute myocardial infection or unstable angina pectoris
研究组 & 干预措施
Moderate renal impairment
Experimental
3h IV POL7080 infusion
干预措施: POL7080 (Drug)
Mild renal impairment
Experimental
3h IV POL7080 infusion
干预措施: POL7080 (Drug)
Severe renal impairment
Experimental
3h IV POL7080 infusion
干预措施: POL7080 (Drug)
End stage renal disease arm 1
Experimental
3h IV POL7080 infusion
干预措施: POL7080 (Drug)
End stage renal disease arm 2
Experimental
3h IV POL7080 infusion
干预措施: POL7080 (Drug)
Normal Renal function
Experimental
3h IV POL7080 infusion
干预措施: POL7080 (Drug)
结局指标
主要结局
To measure the plasma concentrations of POL7080
时间窗: at baseline, 0.5, 1,1.5 and 3 hours after start of infusion, at 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 and 72 hours after end of infusion
次要结局
- Laboratory abnormalities(Screening, Day -1, Day 2, Day 3, and Day 7)
- Adverse events(Daily assessment up to 7 days from informed consent)
研究者
研究点 (1)
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