A Randomized, Open-label, 3-period, Single-dose, Cross-over Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Filgotinib Given as an Oral Mini-tablet Formulation Versus the Oral Tablet Formulation of Filgotinib and to Assess the Effect of Food on the Oral Mini-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 till the last observed quantifiable concentration of filgotinib (AUC0-t)
研究概览
简要总结
Open label study to assess relative bioavailability of filgotinib oral mini-tablet versus oral tablet formulation and effect of food on the mini-tablet formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •A body mass index (BMI) 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. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal range (ULN) and total bilirubin not greater than ULN. Other clinical laboratory safety test results must be within the normal ranges or test results that are outside the normal ranges need to be considered not clinically significant in the opinion of the investigator.
排除标准
- •Known hypersensitivity to filgotinib ingredients or history of a significant allergic reaction to filgotinib ingredients as determined by the investigator.
- •Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.
研究组 & 干预措施
Treatment A:
filgotinib administered under fasting conditions
干预措施: Filgotinib (Drug)
Treatment B:
filgotinib administered under fasting conditions
干预措施: Filgotinib (Drug)
Treatment C:
filgotinib administered under high-fat fed conditions
干预措施: Filgotinib (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero till the last observed quantifiable concentration of filgotinib (AUC0-t)
时间窗: From Day 1 pre-dose until Day 15
Area under the plasma concentration time curve from time zero to infinity of filgotinib (AUC0-inf)
时间窗: From Day 1 pre-dose until Day 15
Maximum observed plasma concentration of filgotinib (Cmax)
时间窗: From Day 1 pre-dose until Day 15
AUC0-t of GS-829845, major active metabolite
时间窗: From Day 1 pre-dose until Day 15
Cmax of GS-829845, major active metabolite
时间窗: From Day 1 pre-dose until Day 15
AUC0-inf of GS-829845, major active metabolite
时间窗: From Day 1 pre-dose until Day 15
次要结局
- Number of participants with treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations(Baseline (Day 1) up to 30 days)