NCT04736927已完成1 期
An Open-label, Fixed-sequence, Drug-drug Interaction Study in Healthy Subjects to Evaluate the Effect of GLPG3667 on the Pharmacokinetics of Midazolam, a Sensitive Index Substrate of CYP3A4
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 14
- 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
A study in healthy volunteers to look at the effect of the test medicine, GLPG3667, on how midazolam (MDZ) is taken up and eliminated by the body.
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, defined as permanently surgically sterile (bilateral oophorectomy, i.e. surgical removal of ovaries, bilateral salpingectomy, i.e. surgical removal of the fallopian tubes, or hysterectomy, i.e. surgical removal of uterus), or with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone level in the postmenopausal range. These female subjects must also have a negative pregnancy test. For surgical sterilization, documented confirmation will be requested.
- •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 enrolment. Neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase, and alanine aminotransferase must be within normal ranges. 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) and/or MDZ ingredients or history of a significant allergic reaction to IP and/or MDZ ingredients 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 for postmenopausal subjects) 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
GLPG3667 + Midazolam
Experimental
干预措施: GLPG3667 (Drug)
GLPG3667 + Midazolam
Experimental
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 until Day 9
To determine the effect of GLPG3667 on the pharmacokinetics (PK) of MDZ.
Maximum observed plasma concentration (Cmax) of MDZ
时间窗: From Day 1 until Day 9
To determine the effect of GLPG3667 on the PK of MDZ.
次要结局
- Cmax of GLPG3667(From Day 3 until Day 8)
- Area under the plasma concentration-time curve over the dosing interval (AUCτ) for GLPG3667(From Day 3 until Day 8)
- Trough plasma concentration observed (Ct) for GLPG3667(From Day 3 until Day 8)
- 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 3 weeks)
研究者
研究点 (1)
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