Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects Following a Single Oral Administration of [14C] GLPG0634
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The amount of total radioactivity in urine and faeces over time after a single dose of radiolabeled GLPG0634
研究概览
简要总结
This will be a study in 6 healthy male subjects, each receiving a single oral dose of 100 mg [14C]-radiolabeled GLPG0634.
The study aims to establish the elimination pathways of GLPG0634 and their relative significance and to assess the metabolite profile of GLPG0634 in plasma and in excreta.
Furthermore, the pharmacokinetics (PK) of the main metabolites in plasma relative to GLPG0634 will be evaluated.
This study will also provide safety and tolerability information for GLPG0634.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male, between 40 and 65 years of age, inclusive
- •within BMI range 18 to 30 kg/m2, inclusive
排除标准
- •Any condition that might interfere with the procedures or tests in this study
- •Drug or alcohol abuse
研究组 & 干预措施
[14C] GLPG0634
Subjects will be dosed with a single oral 100 mg dose of [14C] GLPG0634 on one occasion
干预措施: 100 mg dose of [14C] GLPG0634 (Drug)
结局指标
主要结局
The amount of total radioactivity in urine and faeces over time after a single dose of radiolabeled GLPG0634
时间窗: Day -1 (pre-dosing) up to Day 10 post dosing
To evaluate the mass balance recovery of total radioactivity in urine, faeces, and urine and faeces combined to determine the elimination pathways and their relative significance after a single dose of radiolabeled GLPG0634
The amount of GLPG0634 and its main metabolites in urine and faeces over time after a single dose of radiolabeled GLPG0634
时间窗: Day -1 (pre-dosing) up to Day 10 post dosing
To evaluate the recovery of GLPG0634 and its main metabolites in urine and faeces after a single dose of radiolabeled GLPG0634 to determine the elimination pathways and their relative significance (excretion and renal clearance)
Identification of metabolites over time in plasma, urine and faeces after a single dose of radiolabeled GLPG0634
时间窗: Day -1 (pre-dosing) up to Day 10 post dosing
Metabolite profiling and identification in plasma, urine and faeces over time after a single dose of radiolabeled GLPG0634
The amount of radioactivity, GLPG0634 and its main metabolites in blood and plasma over time after a single dose of radiolabeled GLPG0634
时间窗: Day 1 (pre-dosing) up to Day 8 post dosing
To characterize the amount of radioactivity, GLPG0634 and its main metabolites in blood and plasma over time after a single dose of radiolabeled GLPG0634
次要结局
- Number of adverse events(Screening up to Day 10 post dosing)
- Changes in urine safety lab parameters(Screening up to Day 10 post dosing)
- Changes in vital signs as measured by heart rate, blood pressure and oral temperature(Screening up to Day 10 post dosing)
- Changes in 12-lead ECG measures(Screening up to Day 10 post dosing)
- Changes in physical exam measures(Screening up to Day 10 post dosing)
- Changes in blood safety lab parameters(Screening up to Day 10 post dosing)