A Phase I Study to Compare Pharmacokinetic Parameters of Firibastat and Its Metabolites (EC33 and QGC515) in Healthy Subjects Versus End Stage Renal Disease (ESRD) Patients After a Single Oral Administration of Firibastat 500 mg
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Firibastat and metabolites Concentrations
研究概览
简要总结
The study is a multicentre, open label, phase I, two arms study to compare pharmacokinetic of firibastat after a single oral dose of firibastat 500 mg in fourteen healthy male volunteers and in fourteen End Stage Renal Disease (ESRD) patients not yet in dialysis.
详细描述
It is planned to enroll a total of 28 subjects to receive a single oral dose of investigational medicinal product (IMP): 14 ESRD patients will be enrolled in three Hungarian centres (1st arm) and 14 Healthy volunteers will be enrolled by Eurofins Optimed in Gières, France (2nd arm).
Subjects will be screened for eligibility to participate in the study up to 21 days prior to the first administration. For both arm, subjects will be admitted into the Clinical Research Unit (CRU) on Day -3. On the morning of Day 1, subjects will receive a single 500 mg oral dose of firibastat following an overnight fast (i.e., at least 10 hours). Subjects will be confined to the CRU until discharge on Day 3 with PK blood sample draws for measurement of firibastat and its main metabolites being taken throughout the confinement.
A follow-up post study visit will occur on Day 10 post-dose to ensure the ongoing wellbeing of the subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects, aged 18 to 55 years inclusive;
- •Non-smoker subject or smoker of not more than 5 cigarettes a day;
排除标准
- •Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests);
- •History or presence of drug or alcohol abuse (alcohol consumption > 40 grams/day);
研究组 & 干预措施
Treatment
500 mg (2 capsules of 250 mg)
干预措施: firibastat (Drug)
结局指标
主要结局
Firibastat and metabolites Concentrations
时间窗: Day 1 to Day 3
The plasma concentration data for firibastat (QGC001), EC33 and QGC515, will be analysed at each time measurement (predose, 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose)
次要结局
- Heart Rate (bpm)(Day 1 to Day 3)
- Hematology blood sample laboratory tests aggregated as number of patients outside ranges(Day 1 to Day 3)
- Systolic and Diastolic Blood Pressure (mmHg)(Day 1 to Day 3)
- Urinalysis tests aggregated as number of patients outside ranges(Day 1 to Day 3)
- Biochemistry blood sample laboratory tests aggregated as number of patients outside ranges(Day 1 to Day 3)
- Hemostasis blood sample laboratory tests aggregated as number of patients outside ranges(Day 1 to Day 3)