NCT01348737已完成1 期
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Biomarkers of AZD3839 Including an Open-label Food Effect Group in Healthy Male and Female Volunteers of Non-childbearing Potential
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
- AstraZeneca
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Number of Adverse Event as a measure of safety and tolerability of AZD3839 (Part 1)
研究概览
简要总结
The purpose of the study is to assess the safety, tolerability and blood concentration of AZD3839 following oral administration of single doses in healthy men and women of non-childbearing potential
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 male and female volunteers of non-childbearing potential aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture
- •Have a body mass index (BMI) between 19 and 30 kg/m2 (inclusive) and weigh between 50 kg and 100 kg (inclusive)
- •Creatinine clearance in the normal range (>80 mL/min estimated according to Cockroft-Gault)
- •Healthy volunteers should have a serum potassium concentration of ≥3.8 mmol/L at screening (Visit 1) and on admission to the study centre (Day -1)
- •Clinically normal findings on physical examination in relation to age, as judged by the Investigator
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the healthy volunteer at risk because of participation in the study, or influence the results or the healthy volunteer's ability to participate in the study
- •History of psychotic disorder amongst first degree relatives
- •Significant orthostatic reaction at enrolment as judged by the Investigator
- •Prolonged QTcF greater than 450 msec or shortened QTcF less than 340 msec or family history of long QT syndrome or sudden death
- •Healthy volunteer is a vegetarian/lactose intolerant (exclusion criterion only applicable for healthy volunteers participating in Part 2
研究组 & 干预措施
AZD3839
Experimental
Oral Treatment
干预措施: AZD3839 (Drug)
AZD3839 Placebo
Placebo Comparator
Oral Treatment
干预措施: AZD3839 Placebo (Drug)
结局指标
主要结局
Number of Adverse Event as a measure of safety and tolerability of AZD3839 (Part 1)
时间窗: Part 1 - AEs will be collected from admission to the study centre (Visit 2, Day-1) until the follow-up visit (Visit 3) approximately 15 days
Number of Adverse Events as a measure of Safety and tolerability of AZD3839 (Part 2)
时间窗: Part 2 - AEs will be collected from admission to the study centre (Visit 2, Day-1) until the follow-up visit (Visit 4) approximately 20 days
次要结局
- Time at which maximum concentration occurs in AZD3839 (Part 1)(pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the administration of the investigational product, as well as on Day 4 and at the follow-up visit (Visit 3))
- Maximum observed concentration of AZD3839 in plasma (Part 1)(Part 1 - pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the administration of the investigational product, as well as on Day 4 and at the follow-up visit (Visit 3))
- Time at which maximum concentration occurs in AZD3839 (Part 2)(Part 2 - at pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after the Administration. May be taken at the follow-up visit (Visit 4))
- Maximum observed concentration of AZD3839 in plasma (Part 2)(Part 2 - at pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56 and 72 hours after administration)
研究者
研究点 (1)
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