A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VNRX-5133 With VNRX-5022 in Subjects With Varying Degrees of Renal Impairment

Venatorx Pharmaceuticals, Inc.2 个研究点分布在 1 个国家目标入组 33 人开始时间: 2018年4月6日最近更新: 2019年2月8日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Venatorx Pharmaceuticals, Inc.
入组人数: 33
试验地点: 2
主要终点: Peak Plasma Concentration (Cmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a multi-center, open-label, PK and safety study of VNRX-5133 and VNRX-5022 when co-administered in male and female subjects with varying levels of renal impairment and healthy normal controls.

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 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•BMI: 18.5-40.0 kg/m2 with a minimum weight of 45 kg
•Able and willing to abstain from alcohol from 48 h before admission until the follow-up visit
•Suitable veins for cannulation/multiple venipunctures, as assessed by the Investigator at Screening
•Males who are not surgically sterilized and females of childbearing potential must agree to use highly effective methods of contraception during the study and for 90 days after study drug administration.
•Laboratory values meeting defined entry criteria
•Subjects with normal renal function (Group 1) must also meet the following criteria:
•Match to one or more subjects with renal impairment by gender, age, and weight
•Subjects with renal impairment (Groups 2-5) must also meet the following criteria:
•Stable, pre-existing renal impairment.

排除标准

•Employee of the study site, Contract Research Organization (CRO) or the IND Sponsor
•Female who is pregnant, lactating, or planning to attempt to become pregnant during the study or within 90 days after study drug administration
•Male with a female partner who is pregnant or lactating during the study, or planning to attempt to become pregnant during the study or within 90 days after study drug administration
•Use of any investigational drug or device within 30 days before study drug administration (90 days for an injectable biological agent)
•The subject has a congenital or acquired immunodeficiency syndrome
•Screening or Day -1, clinically significant abnormal ECG values
•Active malignancy; exceptions are permitted for carcinoma in situ of the prostate or the skin (basal cell or squamous cell) are permitted
•History of drug allergy of a severity that required urgent medical treatment, such as treatment with epinephrine in an Emergency Department
•Known immediate hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
•History of donation of more than 450 mL of blood within 60 days before dosing in the site or planned donation before 30 days has elapsed since ingestion of study drug
•Plasma or platelet donation within 7 days of dosing and throughout the study
•Consumes more than 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor) or has a significant history of alcohol abuse or drug/chemical abuse within the last 1 year
•Oral temperature >38.5˚C or acute illness on Day -1
•Previous participation in a study of VNRX-5133
•Excluded concomitant medication

研究组 & 干预措施

Group 1 - Control

Experimental

Healthy control subjects will be matched by gender, weight, and age to subjects with renal impairment