A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG3970 in Healthy Male Subjects Following a Single Oral Dose of GLPG3970 Relative to an Intravenous [14C]GLPG3970 Microtracer and Single Oral [14C]GLPG3970 Administration
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
- Absolute oral bioavailability (F [%]) of GLPG3970
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 tablet and an oral solution.
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
- 30 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male between 30 and 64 years of age (extremes included), on the date of signing the informed consent form (ICF).
- •A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- •Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day).
- •This list only contains the key inclusion criteria.
排除标准
- •Participant has participated in a [14C]radiolabeled study within the past 12 months.
- •Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 month or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 (UK, 2017), cannot participate in the study.
- •This list only contains the key exclusion criteria.
研究组 & 干预措施
Absolute Bioavailability - Period 1
Participants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of [14C]GLPG3970 on Day 1.
干预措施: GLPG3970 film-coated tablet (Drug)
Absolute Bioavailability - Period 1
Participants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of [14C]GLPG3970 on Day 1.
干预措施: [14C]GLPG3970 solution for infusion (Drug)
Mass Balance - Period 2
Participants will receive [14C]GLPG397 under fasted conditions on Day 1.
干预措施: [14]GLPG3970 oral solution (Drug)
结局指标
主要结局
Absolute oral bioavailability (F [%]) of GLPG3970
时间窗: From Day 1 pre-dose until Day 4 in Period 1
Recovery of total radioactivity excreted in urine expressed as a percentage of the administered dose (Ae%).
时间窗: From Day 1 pre-dose until Day 8 in Period 2
Recovery of total radioactivity excreted in feces expressed as a percentage of the administered dose (Ae%).
时间窗: From Day 1 pre-dose until Day 8 in Period 2
次要结局
- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.(From Day 1 through study completion, an average of 1 month)