A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Oral Doses of Tigulixostat on the Pharmacokinetics of a Single Oral Dose of Theophylline
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC0-t of theophylline with and without tigulixostat
研究概览
简要总结
A phase 1, open-label, drug-drug interaction study to evaluate the effect of multiple doses of tigulixostat on the pharmacokinetics of single-dose theophylline in healthy adult volunteers.
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, Ages 18 to 55, inclusive.
- •BMI 18.0 - 32.0 kg/m2, inclusive, at screening.
- •In good general health as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
- •Females of childbearing potential and males who agree to use contraception. Non-pregnant, non-lactating females who must have a negative pregnancy test at screening and check-in.
排除标准
- •Significant history or indications of ill-health, as judged by the investigator.
- •Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion.
- •eGFRcr of <60 (mL/min)/1.73 m2 at screening.
- •alanine aminotransferase, aspartate aminotransferase, or total bilirubin ≥2 times the upper limit of normal at screening and check-in.
- •Used any prescription or over-the-counter medications (except acetaminophen [Tylenol] up to 2 g per day), including herbal or nutritional supplements, within 14 days before the first dose of study drug.
- •Consumed grapefruit or grapefruit juice, Seville orange or Seville orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products within 48 hours before the first dose of study drug.
- •History of hypersensitivity to theophylline or other xanthines and tigulixostat.
研究组 & 干预措施
Cohort 1 (Periods 1-3), Cohort 2 (Periods 1-4)
Period 1: Single oral dose of theophylline (Day 1); Period 2: Once-daily oral doses of tigulixostat (Days 6 to 10); Period 3: Once-daily oral doses of tigulixostat (Days 11 to 13) and a single oral dose of theophylline (Day 11); Period 4: Single oral dose of tigulixostat (Day 19)
干预措施: Tigulixostat (Drug)
Cohort 1 (Periods 1-3), Cohort 2 (Periods 1-4)
Period 1: Single oral dose of theophylline (Day 1); Period 2: Once-daily oral doses of tigulixostat (Days 6 to 10); Period 3: Once-daily oral doses of tigulixostat (Days 11 to 13) and a single oral dose of theophylline (Day 11); Period 4: Single oral dose of tigulixostat (Day 19)
干预措施: Theophylline (Drug)
结局指标
主要结局
AUC0-t of theophylline with and without tigulixostat
时间窗: Up to 72 hours
AUC0-inf of theophylline with and without tigulixostat
时间窗: Up to 72 hours
Cmax of theophylline with and without tigulixostat
时间窗: Up to 72 hours
次要结局
- Incidence of reported adverse events (AEs)(Up to Day 28)
- Cmax of tigulixostat and metabolite GD-MET-1(Up to 24 hours)
- AUC0-t of tigulixostat and metabolite GD-MET-1(Up to 24 hours)