A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419

Galera Therapeutics, Inc.2 个研究点分布在 1 个国家目标入组 26 人开始时间: 2019年4月4日最近更新: 2022年6月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Galera Therapeutics, Inc.
入组人数: 26
试验地点: 2
主要终点: Pharmacokinetic (PK) profile for GC4419 (in plasma): Residual Area

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

The study is a two-center, Phase 1, open-label, single-dose, one-period, four groups, PK study in subjects with various severities of renal impairment and matched healthy controls.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
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

未提供

排除标准

•Subjects to whom any of the following applies will be excluded from Arm 1:
•Any clinically significant abnormality at physical examination or clinically significant abnormal laboratory test results at screening.
•Positive test for hepatitis B, hepatitis C, or HIV at screening;
•History of anaphylaxis, hypersensitivity reaction, or a clinically significant reaction to any drug.
•Clinically significant ECG abnormalities or vital sign abnormalities
•History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit
•History of significant drug abuse within one year prior to screening or use of soft drugs within 3 months prior to the screening visit or hard drugs within 1 year prior to screening
•Participation in a clinical research study within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing
•Positive urine drug screen, alcohol breath test, or urine cotinine test at screening.
•Female subject with positive pregnancy test at screening.
•Breast-feeding or pregnant subject within 6 months prior to study drug administration.
•Use of medication other than topical products without significant systemic absorption and hormonal contraceptives:
•Prescription medication within 14 days prior to dosing;
•Over-the-counter products and natural health products within 7 days prior to dosing
•A depot injection or an implant of any drug within 3 months prior to dosing.
•Donation of plasma within 7 days prior to dosing.
•Inability to be venipunctured and/or tolerate catheter venous access.
•History of myasthenia gravis or carotid sinus sensitivity.
•Subjects to whom any of the following applies will be excluded from Arms 2 to 4:
•Any clinically significant abnormality at physical examination or clinically significant abnormal laboratory test results found during medical screening.
•Positive HIV at screening.
•Female subjects with positive pregnancy test at screening.
•Clinically significant unstable medical conditions or clinically significant acute exacerbation of hepatic disease within 28 days of study drug administration
•Clinically significant abnormalities
•Clinically significant findings on ECG
•Presence of hepatocellular carcinoma or acute hepatic disease from infection or drug toxicity.
•Presence of clinically active stage 3 or stage 4 hepatic encephalopathy.
•Presence of surgically-created or transjugular intrahepatic portal systemic shunts.
•Subjects with a positive urine drug screen or alcohol test at screening.
•Systolic blood pressure lower than 90 or over 160 mmHg, diastolic blood pressure lower than 40 or over 105 mmHg, or heart rate less than 45 or over 100 bpm at screening.
•History of significant drug or alcohol abuse within 6 months prior to screening.
•Participation in another clinical study within 30 days prior to dosing.
•Use of contraindicated medications
•Donation of plasma within 7 days prior to dosing.
•Breast-feeding subject.
•Inability to be venipunctured and/or tolerate catheter venous access.

研究组 & 干预措施

3) Moderate renal impairment

Experimental

干预措施: GC4419 (Drug)

1) Healthy subjects with normal renal function

Experimental

干预措施: GC4419 (Drug)

2) Mild renal impairment

Experimental

干预措施: GC4419 (Drug)

4) Severe renal impairment

Experimental

干预措施: GC4419 (Drug)