NCT02853643已完成1 期
A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect in Healthy Volunteers
Asana BioSciences1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of subjects reporting adverse events during the study
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability, and determine the blood levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of ASN002. Healthy volunteers will be participants in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female, non-smoking subjects.
- •Willing to use contraception throughout the duration of the study and for 90 days after the study.
- •Capable of consent.
排除标准
- •Subjects to whom any of the following applies will be excluded from the study:
- •Any clinically significant abnormality, infection, exposure to infection, recent live virus vaccination, or abnormal laboratory test results found during medical screening.
- •History of alcohol or drug abuse, or a positive urine drug screen or breath alcohol test at screening.
- •History of allergic reactions to protein kinase inhibitors, or significant allergic reactions to any drug.
- •Positive pregnancy test at screening.
- •Clinically significant ECG abnormalities.
- •Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
- •Use of medication other than topical products without significant systemic absorption:
- •Donation of plasma within 7 days prior to dosing, or significant blood loss within the past 56 days.
- •Subject is pregnant, or breast feeding.
研究组 & 干预措施
50 mg Dose
Experimental
Single dose of 50 mg ASN002
干预措施: ASN002 (Drug)
25 mg Dose
Experimental
Single dose of 25 mg ASN002
干预措施: ASN002 (Drug)
100 mg Food effect cross over
Experimental
100 mg single dose under both fasted and fed conditions in a cross over fashion
干预措施: ASN002 (Drug)
结局指标
主要结局
Number of subjects reporting adverse events during the study
时间窗: Days 1-28
Safety and tolerability will be determined by the number of subjects reporting adverse events during the study.
次要结局
- Drug half life of ASN002(Days 1-6)
- Maximum Plasma Concentration of ASN002(Days 1-6)
- Drug half life of ASN002 under fed and fasted conditions(Days 1-6)
- Area under the plasma concentration versus time curve (AUC) under fed and fasted conditions(Days 1-6)
- Area under the plasma concentration versus time curve (AUC)(Days 1-6)
- Maximum Plasma Concentration of ASN002 under fed and fasted conditions(Days 1-6)
研究者
研究点 (1)
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