An Open-label, Fixed-sequence Drug-drug Interaction Study in Healthy Subjects to Evaluate the Effect of GLPG4716 on the Pharmacokinetics of Nintedanib and Pirfenidone
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- AUC0-inf of nintedanib
研究概览
简要总结
The main aim of this study is to investigate the possible effect of GLPG4716 on the pharmacokinetics (PK) of pirfenidone and nintedanib. Further aims are to investigate safety and tolerability of GLPG4716 alone or administered simultaneously with pirfenidone or nintedanib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). Female subjects should be of non-childbearing potential.
- •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, electrocardiogram (ECG), and fasting clinical laboratory safety tests. Aspartate transaminase and alanine aminotransferase must be no greater than the upper limit of normal (ULN). 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 includes the key inclusion criteria.
排除标准
- •Known hypersensitivity to ingredients of GLPG4716, pirfenidone, or nintedanib or history of a significant allergic reaction to ingredients of GLPG4716, pirfenidone, or nintedanib 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, and hormonal replacement therapy) 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.
- •This list only includes the key exclusion criteria.
研究组 & 干预措施
GLPG4716 and pirfenidone
干预措施: Pirfenidone (Drug)
GLPG4716 and pirfenidone
干预措施: GLPG4716 (Drug)
GLPG4716 and nintedanib
干预措施: GLPG4716 (Drug)
GLPG4716 and nintedanib
干预措施: Nintedanib (Drug)
结局指标
主要结局
AUC0-inf of nintedanib
时间窗: From Day 1 pre-dose until Day 15
To determine the effect of GLPG4716 on the PK of nintedanib.
Maximum observed plasma concentration (Cmax) of pirfenidone
时间窗: From Day 1 pre-dose until Day 15
To determine the effect of GLPG4716 on the PK of pirfenidone
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of pirfenidone
时间窗: From Day 1 pre-dose until Day 15
To determine the effect of GLPG4716 on the PK of pirfenidone
Cmax of nintedanib
时间窗: From Day 1 pre-dose until Day 15
To determine the effect of GLPG4716 on the PK of nintedanib.
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 2 months)