NCT01116258已完成1 期
A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5847 Following Oral Administration to Healthy Male Subjects and Female Subjects 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
- 60
- 试验地点
- 1
- 主要终点
- Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and blood levels of AZD5847 after daily oral dosing for 14 days.
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
- Quadruple (Participant, Care Provider, 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
- •BMI between 18-30
排除标准
- •Use of drugs that inhibit or induce cytochrome P450 3A4 enzymes
- •History of presence of gastrointestinal, hepatic or renal disease
研究组 & 干预措施
1
Experimental
干预措施: AZD5847 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
时间窗: collected prior to treatment, during treatment, and follow-up for a total of 25 to 52 days(includes upto 28 days for screening)
次要结局
- characterize the Pharmacokinetics of AZD9742 in blood and urine(PK-sampling during 14 pre-defined study days for PK profiling)
研究者
研究点 (1)
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