A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG1205 in Healthy Male Subjects Following Single Intravenous [14C]-GLPG1205 Microtracer and Single Oral [14C]-GLPG1205 Administration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Absolute oral bioavailability (F) (%)
研究概览
简要总结
A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a capsule or tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male between 18-64 years of age (extremes included) (Part 1) and between 45-64 years of age (extremes included) (Part 2), on the date of signing the informed consent form.
- •A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive.
- •Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day).
排除标准
- •Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, cannot participate in the study.
研究组 & 干预措施
GLPG1205 oral and [14C]-GLPG1205 IV
Single oral dose of GLPG1205 followed by [14C]-GLPG1205 solution for infusion
干预措施: GLPG1205 film-coated tablets (Drug)
GLPG1205 oral and [14C]-GLPG1205 IV
Single oral dose of GLPG1205 followed by [14C]-GLPG1205 solution for infusion
干预措施: [14C]-GLPG1205 solution for infusion (Drug)
[14C]-GLPG1205 capsule
Single oral dose of GLPG1205 as solid formulation
干预措施: GLPG1205 capsules (Drug)
结局指标
主要结局
Absolute oral bioavailability (F) (%)
时间窗: Between Day 1 and Day 22
To determine the absolute bioavailability of an oral dose of GLPG1205 relative to an intravenous (i.v.) microtracer dose of \[14C\]-GLPG1205
Recovery of total radioactivity in urine and feces measured as amount of [14C]-GLPG1205 excreted as percentage of the administered dose (Ae%)
时间窗: Between Day 1 and Day 22
To assess the mass balance recovery after a single oral dose of \[14C\]-GLPG1205
次要结局
未报告次要终点