NCT00963365撤回1 期
Pt. A: Ph I, Sngl-Blind, Randomized, Pcbo-Controlled 3-Way Crossover Study Followed by an Open-label Food Effect Study to Assess the PK of IV and Oral AZD6765 in Healthy Male and Female Subjects Pt.B: Ph I, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and PK of AZD6765 When Administered in Multiple Ascending Doses to Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 试验地点
- 1
- 主要终点
- The objective of the study is to investigate the safety and tolerability of AZD6765 when administered orally in single and multiple doses to healthy subjects by assessment of adverse events, vital signs, physical examinations, electrocardiograms(ECG).
研究概览
简要总结
The purpose of this study is to determine the safety of AZD6765 when given in single and multiple oral doses and to compare an oral and intravenous (IV) formulation of AZD6765 to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Females must be of non-childbearing potential.
排除标准
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product.
- •Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months (if half-life was < 24 hours) of the first administration of study drug
- •Plasma or blood product donation within one month of screening or any blood donation/blood loss > 500mL during the 3 months prior to screening.
研究组 & 干预措施
AZD6765 oral solution
Experimental
Active
干预措施: AZD6765 (Drug)
AZD6765 IV infusion
Experimental
Active
干预措施: AZD6765 (Drug)
Placebo to AZD6765 oral solution
Placebo Comparator
Placebo
干预措施: AZD6765 (Drug)
Placebo to AZD6765 IV infusion
Placebo Comparator
Placebo
干预措施: AZD6765 (Drug)
结局指标
主要结局
The objective of the study is to investigate the safety and tolerability of AZD6765 when administered orally in single and multiple doses to healthy subjects by assessment of adverse events, vital signs, physical examinations, electrocardiograms(ECG).
时间窗: Safety assessments are made prior to and after drug administration.
次要结局
- Part A 1. To characterize the single dose pharmacokinetics of AZD67652. To assess the absolute bioavailability of AZD67653. To assess the effect of food on the pharmacokinetics of AZD6765(Blood samples will be obtained on Days 1-5.)
- Part B 1. To characterize the single and multiple dose pharmacokinetics of AZD6765 2. To assess dose linearity and proportionality of AZD67653. To assess the degree of accumulation and the time dependence of the pharmacokinetics of AZD6765(Blood samples will be obtained on Days 1-4 and 7-11.)
研究者
研究点 (1)
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