NCT00935025终止1 期
A Single-center, Single-blind, Randomized, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Oral Doses of AZD1305 Extended-release Capsules in Healthy Male Japanese and Caucasian Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight
研究概览
简要总结
This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305 extended-release capsules in healthy male Japanese and Caucasian subjects. Three (or four if needed) dose levels will be given to Japanese subjects and one of the doses will also be given to Caucasian subjects.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese and Caucasian male subjects 20 to 45 years of age inclusive
- •Body weight between 50 and 85 kg, inclusive, with a Body Mass Index (BMI) ≥19 to ≤ 27 kg/m2
排除标准
- •Clinically significant illness, surgical procedure or trauma, within two weeks preceding the pre-entry visit until first administration of IP, as judged by the investigator
- •History of clinically significant gastrointestinal, mental, cardiac, renal or hepatic disorder, or other significant disease as judged by the investigator
- •Habitual smoker (daily use) of tobacco or daily use of nicotine-containing products
研究组 & 干预措施
1, AZD1305
Experimental
干预措施: AZD1305 (Drug)
2, Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight
时间窗: During the study, from screening period to follow-up, 50 days approximately
次要结局
- Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma and urine after single and repeated oral doses(From predose until 48 hrs post last dose)
研究者
研究点 (1)
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