临床试验/NCT00674856

NCT00674856已完成1 期

A Phase 1 Repeated Dose Open Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750mg Bid Administered to Patients With Impaired Renal Function Compared to Matching Healthy Subjects

NicOx0 个研究点目标入组 32 人开始时间: 2008年5月最近更新: 2009年1月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: NicOx
入组人数: 32
主要终点: To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects.

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记录与标识符相似试验

研究概览

简要总结

To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function

详细描述

This is an 8-day, repeated dose, open label study to investigate the pharmacokinetics and safety of naproxcinod in order to guide initial dosing and achieve the optimal dose of naproxcinod in Renal impaired patients.

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: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Male or female aged 18 to 75 years with stable mild to moderate renal insufficiency.
•Male or female aged 18 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health

排除标准

•Any significant acute or chronic disease (except renal impairment) which may interfere with study evaluations.
•A history of alcohol or drug abuse.
•Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
•Clinically relevant abnormal ECG
•Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except low dose aspirin (less than or equal to 325mg per day).
•Participation within 30 days prior to screening in another investigational study.

研究组 & 干预措施

naproxcinod

Experimental

naproxcinod 750mg(375mg caps x2), administered twice a day.

干预措施: naproxcinod (Drug)

结局指标

主要结局

To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects.

时间窗: 8 days

次要结局

To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects.(8 days)
To assess the general safety of naproxcinod in renal impaired patients and in healthy subjects as shown by the biological tolerance and the adverse events (AE) profile.(8 days)

研究者

发起方

NicOx

申办方类型

Industry

相似试验

已完成

1 期

A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy SubjectsLiver Disease

NCT00621881NicOx24

已完成

1 期

A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal FunctionRenal Impairment

NCT05940402AbbVie58

已完成

1 期

Study of the Effect of Renal Impairment on the Pharmacokinetics of VepoloxamerPharmacokinetics of VepoloxamerHealthy VolunteersRenal Impaired

NCT02646358Mast Therapeutics, Inc.27

已完成

1 期

A Phase 1 Study of Roxadustat in Subjects With Different Degrees of Renal FunctionNormal Renal FunctionImpaired Renal Function

NCT02965040Astellas Pharma Europe B.V.34

已完成

1 期

Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)Renal ImpairmentType 2 Diabetes Mellitus

NCT01948986Merck Sharp & Dohme LLC36