NCT00813670已完成1 期
Phase 1, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XPF-001 and to Investigate the Effect of Food on the Pharmacokinetics of a Single Dose of XPF-001 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events.
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple doses of XPF-001 in healthy volunteers.
The effect of food on the pharmacokinetics of XPF-001 will also be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects (Females of non-childbearing potential) with normal or clinically insignificant laboratory results, ECGs and physical examinations.
排除标准
- •Subjects with a presence or history of any clinically significant disease.
- •Subjects who have participated in and investigational drug trial within 60 days of admission.
- •Subjects who have used tobacco or nictoine products in the 1 month prior to admission
- •Females who are pregnant or breastfeeding
研究组 & 干预措施
Cohort 1: Single dose of XPF-001
Experimental
干预措施: XPF-001 (Drug)
Cohort 2: Single dose of XPF-001
Experimental
干预措施: XPF-001 (Drug)
Cohort 3: Single dose of XPF-001
Experimental
干预措施: XPF-001 (Drug)
Cohort 4: Single dose of XPF-001
Experimental
干预措施: XPF-001 (Drug)
Cohort 5: Single dose of XPF-001
Experimental
干预措施: XPF-001 (Drug)
Cohort A: Repeated doses of XPF-001
Experimental
干预措施: XPF-001 (Drug)
Cohort B: Repeated doses of XPF-001
Experimental
干预措施: XPF-001 (Drug)
Cohort C: Repeated doses of XPF-001
Experimental
干预措施: XPF-001 (Drug)
结局指标
主要结局
ECGs, Telemetry, Vital Signs, Physical Examinations, Laboratory Assessments and Adverse Events.
时间窗: up to 14 days post dose
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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