A Phase 1, Open-Label, 2-Cohort Study to Assess the Single Dose Pharmacokinetics of Two Formulations of TD-1473 and to Assess the Effect of a High-Fat Meal and Itraconazole on the Pharmacokinetics of TD-1473 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Apparent clearance (Cl/F) in Plasma
研究概览
简要总结
This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 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 to 55 years old
- •Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
- •Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
- •Body Mass Index (BMI) 18 to 32 kg/m2
- •Willing and able to give informed consent
- •Additional inclusion criteria apply
排除标准
- •Planning to conceive a child during the study or within 2 months after the last dose of study drug
- •Is positive for hepatitis A, B or C, and/or HIV
- •Has clinically significant abnormalities in baseline laboratory evaluations
- •Subject has a clinically significant abnormal electrocardiogram (ECG)
- •Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device)
- •Additional exclusion criteria apply
研究组 & 干预措施
TD-1473 formulation bridging & food effect
Subjects will receive, on Day 1 of each period, a single 100 mg oral dose of the tablet formulation of TD-1473 in the fed or fasted state, or the PIC formulation of TD-1473 in the fasted state, as part of a 3-period, crossover design.
干预措施: TD-1473 (Drug)
TD-1473 with Itraconazole
Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1. In Period 2, subjects will receive, in the fasted state, single oral doses of 200 mg itraconazole solution on Days -4 through 7 for a total of 11 days, with a single 100 mg oral dose of the tablet formulation of TD-1473 co-administered on Day 1.
干预措施: TD-1473 (Drug)
TD-1473 with Itraconazole
Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1. In Period 2, subjects will receive, in the fasted state, single oral doses of 200 mg itraconazole solution on Days -4 through 7 for a total of 11 days, with a single 100 mg oral dose of the tablet formulation of TD-1473 co-administered on Day 1.
干预措施: Itraconazole (Drug)
TD-1473 without Itraconazole
Subjects will receive a single 100 mg oral dose of the tablet formulation of TD-1473 in the fasted state on Day 1 of Period 1.
干预措施: TD-1473 (Drug)
结局指标
主要结局
Apparent clearance (Cl/F) in Plasma
时间窗: Up to 8 days post-dose
Time to maximum observed concentration (tmax) in Plasma
时间窗: Up to 8 days post-dose
Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma
时间窗: Up to 8 days post-dose
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma
时间窗: Up to 8 days post-dose
Apparent volume of distribution (Vz/F) in Plasma
时间窗: Up to 8 days post-dose
Maximum observed concentration (Cmax) in Plasma
时间窗: Up to 8 days post-dose
Apparent terminal elimination half-life (t1/2) in Plasma
时间窗: Up to 8 days post-dose
次要结局
未报告次要终点