A Randomized, Open-label, 3-period, Single-dose, Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of GLPG3970 Given as an Oral Tablet Formulation Versus the Oral Solution Formulation of GLPG3970 and to Assess the Effect of Food on the Oral Tablet Formulation.
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
- Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
研究概览
简要总结
This is a study to assess the relative bioavailability of a GLPG3970 oral tablet formulation compared to an oral solution formulation and the effect of food on the bioavailability of a single dose of the oral tablet formulation of GLPG3970. It will also evaluate the safety and tolerability of a single dose of GLPG3970.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subject between 18 and 55 years of age (extremes included), on the date of signing the informed consent form .
- •A body mass index between 18.0 and 30.0 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 electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Total bilirubin, aspartate aminotransferase, and alanine aminotransferase must be no greater than 1.5x upper limit of normal range. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.
- •This list only contains the key inclusion criteria.
排除标准
- •Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
- •This list only contains the key exclusion criterion.
研究组 & 干预措施
GLPG3970 tablet fasted
Single oral dose of GLPG3970 in fasted conditions
干预措施: GLPG3970 tablet (Drug)
GLPG3970 tablet fed
Single oral dose of GLPG3970 in fed conditions
干预措施: GLPG3970 tablet (Drug)
GLPG3970 solution
Single oral dose of GLPG3970 in fasted conditions
干预措施: GLPG3970 oral solution (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf)
时间窗: Between Day 1 pre-dose and Day 4
To assess the BA of a GLPG3970 oral tablet formulation (test) relative to that of an oral solution formulation (reference). To assess the effect of food on BA of a single oral dose of the oral tablet formulation of GLPG3970.
Area under the plasma concentration-time curve from time zero until the last observed quantifiable concentration (AUC0-t)
时间窗: Between Day 1 pre-dose and Day 4
To assess the BA of a GLPG3970 oral tablet formulation (test) relative to that of an oral solution formulation (reference). To assess the effect of food on BA of a single oral dose of the oral tablet formulation of GLPG3970.
Maximum observed plasma concentration (Cmax) of GLPG3970
时间窗: Between Day 1 pre-dose and Day 4
To assess the bioavailability (BA) of a GLPG3970 oral tablet formulation (test) relative to that of an oral solution formulation (reference). To assess the effect of food on BA of a single oral dose of the oral tablet formulation of GLPG3970.
次要结局
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity(From Day 1 through study completion, an average of 1 month)