Interventional, Open-label, One-sequence Study to Investigate the Effects of Multiple Doses of Foliglurax on the Pharmacokinetics of Cytochrome P450 (CYP450) Substrates Caffeine (CYP1A2), Montelukast (CYP2C8), and Midazolam (CYP3A4) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to help determine which types of drugs that may interact with foliglurax
详细描述
This study is designed to evaluate the PK of caffeine, montelukast and midazolam following multiple doses of foliglurax in healthy subjects. The study is divided into four periods:
- Period 1: investigation of the CYP450 probe substrates (caffeine, montelukast, midazolam) alone followed by a 2-day washout before start of Period 2.
- Period 2: administration of foliglurax for 7 days to reach steady state.
- Period 3: administration of the CYP450 probe substrates in combination with foliglurax followed by a 7-day washout before start of Period 4.
- Period 4: investigation of the effects of foliglurax on the PK of the CYP450 probe substrates following washout of foliglurax.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 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
- •Healthy men and women with a body mass index (BMI) of ≥ 18.5 and ≤ 30 kg/m2 and a minimum body weight of 60 kg for men and 50 kg for women.
- •Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status.
排除标准
- •The subject has a regular intake of more than 500 mg of caffeine per day or impossibility to stop intake, on holidays for example, without headaches forcing to take caffeine again.
- •Other in- and exclusion criteria may apply
研究组 & 干预措施
Foliglurax
Foliglurax, iv midazolam and cocktail of CYP450 probe substrates
干预措施: Drug Cocktail (Drug)
Foliglurax
Foliglurax, iv midazolam and cocktail of CYP450 probe substrates
干预措施: Foliglurax (Drug)
Foliglurax
Foliglurax, iv midazolam and cocktail of CYP450 probe substrates
干预措施: midazolam iv (Drug)
结局指标
主要结局
Cmax
时间窗: Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates
Maximum observed plasma concentration of midazolam after iv administration and for all oral cocktail probe substrates
AUC0-inf
时间窗: Day 1 and 11 for midazolam iv and Day 2,12 and 20 for oral cocktail probe substrates
Area under the plasma concentration-time curve from zero to infinity for midazolam after iv administration and for all oral cocktail probe substrates
次要结局
未报告次要终点