跳至主要内容
临床试验/NCT00935025
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

AstraZeneca1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2009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
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

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

发起方
AstraZeneca
申办方类型
Industry

研究点 (1)

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