A Phase 1, Open-Label, Fixed Sequence, 1-way Crossover Study Examining the Effect of Itraconazole on the Pharmacokinetics, Safety and Tolerability After Varegacestat Single Dose Administration to Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Effect of itraconazole on the PK of varegacestat in healthy participants.
研究概览
简要总结
This is an open label, fixed sequence, 1-way crossover drug-drug interaction (DDI) study in healthy participants.
详细描述
This is a phase 1, open-label, fixed sequence, 1-way crossover study examining the effect of itraconazole on the pharmacokinetics, safety and tolerability after varegacestat single dose administration to healthy participants. This is a 2-period study. In period 1 a single dose of varegacestat will be administered with PK evaluated predose and up to 192 hours postdose. There will be a 14 -day washout between period 1 and period 2. In period 2, itraconzole will be administered once daily for 18 consecutive days. Beginning on Day 4 of Period 2 a single dose of varegacestat will be administered 30 minutes after itraconazole dosing. Blood samples for PK will be collected prior to varegacestat dosing and up to 744 hours post varegacestat dosing for varegacestat and its metabolite.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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, adult, male or female (of non-childbearing potential only), 18 to 55 years of age, inclusive, at the screening visit.
- •Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee
排除标准
- •Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- •History of any illness that, in the opinion of the PI or designee might confound the results of the study or poses an additional risk to the participant by their participation in the study.
研究组 & 干预措施
Treatment Arm
Period 1: varegacestat administration for PK followed by Period 2: itraconazole and varegacestat administration for PK and DDI
干预措施: varegacestat (Drug)
Treatment Arm
Period 1: varegacestat administration for PK followed by Period 2: itraconazole and varegacestat administration for PK and DDI
干预措施: Itraconazole (200 mg) (Drug)
结局指标
主要结局
Effect of itraconazole on the PK of varegacestat in healthy participants.
时间窗: Up to 5 weeks
Tmax for varegacestat administered with and without itraconazole.
次要结局
- Safety and tolerability of varegacestat in the presence of itraconazole in healthy participants.(Up to 2 months)
- Ctrough of itraconazole and hydroxy-itraconazole in combination with varegacestat in healthy participants.(Up to 5 weeks)