A Phase 1, Open-label, Single-center Study to Investigate the Pharmacokinetics and Metabolism of GLPG1972 in Healthy Male Subjects Following Single Intravenous [14C]-GLPG1972 Microtracer and Single Oral [14C]-GLPG1972 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
- Change of total radioactivity excreted in urine and feces combined (Period 2)
研究概览
简要总结
The sponsor wants to investigate in this study how well the test medicine is taken up by the body when given orally (by mouth) as a tablet and solution, and as a solution for infusion (into a vein). The oral solution and solution for infusion will be radiolabelled. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body, what it is broken down into, and how it leaves the body.
The sponsor will also look at the safety and tolerability of the test medicine.
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 30-64 years of age (extremes included), on the date of signing the Informed Consent Form (ICF).
- •A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive.
- •Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or considered not clinically significant in the opinion of the investigator.
- •Having a regular daily defecation pattern (i.e. 1 to 3 times per day).
排除标准
- •Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hayfever is allowed unless active.
- •History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection).
- •Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first investigational medicinal product (IMP) administration.
- •Participation in a study with 14C-radiolabeled drug in the last 12 months prior to first IMP administration.
- •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 months or 10 millisievert (mSv) in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, can participate in the study.
研究组 & 干预措施
GLPG1972 oral and [14C]-GLPG1972 IV
GLPG1972 film-coated tablet followed by [14C]-GLPG1972 solution for infusion
干预措施: GLPG1972 film-coated tablets (Drug)
GLPG1972 oral and [14C]-GLPG1972 IV
GLPG1972 film-coated tablet followed by [14C]-GLPG1972 solution for infusion
干预措施: [14C]-GLPG1972 solution for infusion (Drug)
[14C]-GLPG1972 oral solution
[14C]-GLPG1972 oral solution
干预措施: [14C]-GLPG1972 oral solution (Drug)
结局指标
主要结局
Change of total radioactivity excreted in urine and feces combined (Period 2)
时间窗: From Day 1 pre-dose up to Day 10
To assess the mass balance, using \[14C\]-GLPG1972
Area under the plasma concentration-time curve (AUC) of total radioactivity (Period 2)
时间窗: From Day 1 pre-dose up to Day 10
To assess the PK of GLPG1972 and its main metabolites in plasma
Change in amount of [14C]-GLPG1972 excreted in urine and feces combined (μg) from baseline at Day 7 (Part 2)
时间窗: From Day 1 pre-dose up to Day 7
To characterize the elimination pathways and metabolite profile of GLPG1972
Maximum observed plasma concentration (Cmax) of total radioactivity (Period 2)
时间窗: From Day 1 pre-dose up to Day 10
To assess the pharmacokinetics (PK) of GLPG1972 and its main metabolites in plasma
Cmax of GLPG1972 (Period 2)
时间窗: From Day 1 pre-dose up to Day 10
To assess the PK of GLPG1972 and its main metabolites in plasma
AUC of GLPG1972 (Period 2)
时间窗: From Day 1 pre-dose up to Day 10
To assess the PK of GLPG1972 and its main metabolites in plasma
次要结局
- IV Cmax of total radioactivity (Period 1)(From Day 1 pre-dose up to Day 4)
- IV AUC of total radioactivity (Period 1)(From Day 1 pre-dose up to Day 4)
- The number of incidents of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuations (Period 1 and Period 2)(From Day 1 through study completion, an average of 2 months)
- IV AUC of [14C]-GLPG1972 MT (Period 1)(From Day 1 pre-dose up to Day 4)
- Intravenous (IV) Cmax of [14C]-GLPG1972 microtracer (MT)(Period 1)(From Day 1 pre-dose up to Day 4)