An Open-label, Fixed Sequence, Drug-drug Interaction Study in Healthy Subjects to Evaluate the Effect of GLPG4716 on the Pharmacokinetics of Midazolam, a Sensitive Index Substrate of CYP3A4, and to Assess the Effect of Food on the Pharmacokinetics of GLPG4716
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MDZ
研究概览
简要总结
The purpose of this study is to determine the effect of the administration of multiple doses of GLPG4716 on the amount of midazolam (MDZ) that gets into the blood when the two drugs are administered together compared to when midazolam is administered alone. Other objectives of this study are to evaluate the safety and tolerability of GLPG4716 when administered with midazolam and assess the amount of GLPG4716 that gets into the blood when administered with midazolam. This study will also assess the effect of food on the amount of GLPG4716 that gets into the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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. Female subjects should be of non-childbearing potential.
- •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
- •Oxygen saturation
- •12-lead electrocardiogram
- •Fasting clinical laboratory safety tests. Aspartate aminotransferase and alanine aminotransferase must be no greater than 1.5x upper limit of normal range and total bilirubin no greater than 1x upper limit of normal. 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 ingredients of GLPG4716 and/or MDZ
- •History of a significant allergic reaction to ingredients of GLPG4716 and/or MDZ as determined by the investigator.
- •Treatment with any medication including:
- •Over-the-counter 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 contains the key exclusion criteria.
研究组 & 干预措施
GLPG4716 and Midazolam
干预措施: GLPG4716 (Drug)
GLPG4716 and Midazolam
干预措施: Midazolam (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of MDZ
时间窗: From Day 1 pre-dose until Day 15
To determine the effect of GLPG4716 on the PK of MDZ
Maximum observed plasma concentration (Cmax) of MDZ
时间窗: From Day 1 pre-dose until Day 15
To determine the effect of GLPG4716 on the pharmacokinetics (PK) of MDZ
次要结局
- Area under the plasma concentration-time curve over the dosing interval (AUCt) of GLPG4716(From Day 1 pre-dose until Day 15)
- Cmax of GLPG4716(From Day 1 pre-dose until Day 15)
- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent (SAEs), and TEAEs leading to treatment discontinuations(From Day 1 through study completion, an average of one month)