NCT01116011已完成1 期
A Phase I, Single-Centre, Randomised, Double-Blind, Placebo-controlled, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Japanese Healthy Male Subjects
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
- 30
- 试验地点
- 1
- 主要终点
- Investigate the safety and tolerability of AZD7268 by Adverse Events.
研究概览
简要总结
This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Provision of Informed Consent
- •Healthy male subjects, with suitable veins for cannulation or repeated venipuncture
排除标准
- •Inability to understand or cooperate with given information
- •Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test
- •History of seizure (including infant febrile seizures) or family history of seizure
研究组 & 干预措施
AZD7268
Experimental
干预措施: AZD7268 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Investigate the safety and tolerability of AZD7268 by Adverse Events.
时间窗: From first dosing throughout the treatment period and including the follow-up period
次要结局
- Characterize the PK parameters(Cmax, AUC,t1/2) of AZD7268 by assessment of drug concentrations in plasma(Blood samples will be taken from pre-dose until 48 hours post last dose)
- Characterize the PK parameters (CLr, Ae) of AZD7268 by assessment of drug concentrations in urine(Urine samples will be taken from post first dose until 48 hours post last dose.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy VolunteersHealthyNCT00861718AstraZeneca40
已完成
1 期
AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19COVID-19NCT04507256AstraZeneca60
已完成
2 期
A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic SubjectsAsthmaNCT03622112AstraZeneca808
已完成
1 期
Multiple-Dose, Dose-Escalation Study to Evaluate the Safety/Tolerability and Pharmacokinetics of FP-045Healthy VolunteersNCT03686930Foresee Pharmaceuticals Co., Ltd.24
已完成
1 期
A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 DiabetesType 2 DiabetesNCT02524782MedImmune LLC103