NCT02072993终止1 期
A Phase I, Single-center, Single-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral AZD1979 After Single-ascending Doses in Healthy Male Volunteers
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
- 116
- 试验地点
- 1
- 主要终点
- Safety variables in terms of: Adverse events, clinical laboratory variables, vital signs, electrocardiograms and telemetry, physical examinations, and assessments of anxiety and mood
研究概览
简要总结
This is a first time in human study to assess the safety and tolerability of AZD1979 following oral administration of single ascending doses in healthy male volunteers. Pharmacokinetics (what the body does to the drug) parameters will also be assessed as secondary objectives.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated, written informed consent prior to any study specific procedures
- •Healthy male volunteer aged 18 to 50 years
- •Have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg and no more than 100 kg, inclusive
排除标准
- •History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- •History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- •Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IP
- •Any clinically important abnormalities in clinical chemistry, endocrine hormones, hematology, or urinalysis results as judged by the Investigator
研究组 & 干预措施
AZD1979
Experimental
Single ascending doses of oral solution AZD1979
干预措施: AZD1979 (Drug)
Placebo
Placebo Comparator
Placebo to match single ascending doses of oral solution AZD1979
干预措施: Placebo to match (Drug)
结局指标
主要结局
Safety variables in terms of: Adverse events, clinical laboratory variables, vital signs, electrocardiograms and telemetry, physical examinations, and assessments of anxiety and mood
时间窗: Up to 62 days
次要结局
- Pharmacokinetics of AZD1979 assessed by means of plasma concentration analyses(up to 48 hours post dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD0914Gonococcal (GC) InfectionNCT01929629AstraZeneca100
已完成
1 期
AZD8529 Multiple Ascending Dose Study in Healthy SubjectsHealthy VolunteerNCT00765492AstraZeneca47
已完成
1 期
AZD7325 Multiple Ascending Dose StudyHealthy VolunteerNCT00681915AstraZeneca48
已完成
1 期
A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy SubjectsChronic Obstructive Pulmonary Disease (COPD)NCT01754844AstraZeneca57
已完成
1 期
AZD8529 Single Ascending Dose StudyHealthy VolunteerNCT00755378AstraZeneca58