A Phase 1, Open-Label, Fixed Sequence Study to Investigate the Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740 in Healthy Adult 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
- AUC0-24 of CRD-740 alone and with coadministration of itraconazole
研究概览
简要总结
This is a Phase 1, single-site, open-label, fixed sequence crossover study to investigate the effect of coadministration of itraconazole on the pharmacokinetics of CRD-740 in healthy male and female subjects. Subjects will be admitted into the study site on Day -1 and will be confined to the study site until discharge on Day 16. Subjects will receive CRD-740 orally on Days 1 and 10. Itraconazole will be given once daily, orally, on Days 7 through 15.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Males or females, of any race, between 18 and 55 years of age, inclusive.
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- •In good health, determined by no clinically significant findings as assessed by the investigator.
- •Adhere to all contraception criteria.
排除标准
- •Significant medical history as determined by the investigator.
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including itraconazole, unless approved by the investigator (or designee).
- •History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- •Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator.
- •History or presence of an abnormal ECG.
- •Use or intend to use any medications/products/herbal remedies known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee).
- •Drugs affecting CYP3A4 should be refrained from use for 3 weeks, or 5 half-lives (whichever is longer), prior to check-in through to follow-up.
- •Positive urine drug screen at screening or positive alcohol breath test result or positive urine drug screen at check-in.
- •History of alcoholism or drug/chemical abuse within 12 months prior to check-in.
- •Ingestion of poppy seed, Seville orange, or grapefruit containing foods or beverages within 7 days prior to check-in.
研究组 & 干预措施
CRD-740 and Itraconazole
CRD-740 single dose administered with Itraconazole
干预措施: CRD-740 (Drug)
CRD-740 and Itraconazole
CRD-740 single dose administered with Itraconazole
干预措施: Itraconazole (Drug)
CRD-740
CRD-740 single dose administered alone
干预措施: CRD-740 (Drug)
结局指标
主要结局
AUC0-24 of CRD-740 alone and with coadministration of itraconazole
时间窗: Day 1 to Day 16
Cmax of CRD-740 alone and with coadministration of itraconazole
时间窗: Day 1 to Day 16
AUC0-inf of CRD-740 alone and with coadministration of itraconazole
时间窗: Day 1 to Day 16
AUC0-t of CRD-740 alone and with coadministration of itraconazole
时间窗: Day 1 to Day 16
次要结局
- Time to maximum concentration (Tmax) of CRD-740(Day 1 to Day 16)
- Half life (t1/2) of CRD-740(Day 1 to Day 16)
- Oral clearance (CL/F) of CRD-740(Day 1 to Day 16)
- Apparent volume of distribution during terminal phase (Vz/F) of CRD-740(Day 1 to Day 16)