NCT01148095已完成1 期
A Single Centre Two Part Randomized Phase I Study to Assess the Pharmacokinetics of an ER Formulation of AZD2516 and to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 After Multiple Ascending Doses in Healthy Volunteers
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
- 6
- 试验地点
- 1
- 主要终点
- Adverse Events, vital signs
研究概览
简要总结
AZD2516 is being developed for the oral treatment of chronic neuropathic pain. This study is split in to two parts. Part A will measure the effect of food and a new formulation of the drug in the blood and see how well it is tolerated. Part B will commence after the completion of Part A and will investigate the safety and tolerability of daily dosing with AZD2516.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
- •Healthy volunteers able and willing to comply with all study requirements.
排除标准
- •An ongoing or history of a medical or psychiatric disease/condition which may put the healthy volunteer at risk or interfere with the study objectives because of participation in the study, as judged by the investigator(s).
- •History of psychotic disorder among first degree relatives.
研究组 & 干预措施
1
Experimental
AZD2516 (dose escalating)
干预措施: AZD2516 (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Events, vital signs
时间窗: Day -1 until follow-up
次要结局
- Maximum plasma concentration (Cmax)(Day 1 - Day 12)
- Time to Cmax (tmax)(Day 1 - Day 12)
- Terminal rate constant (λz)(Day 1 - Day 12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability, and Pharmacokinetics of Oral EC5026 in Healthy SubjectsHealthy AdultsNCT04228302EicOsis Human Health Inc.40
已完成
2 期
A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic PainDiabetesNCT02412852TheraVasc Inc.26
终止
2 期
Study to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Peripheral Neuropathic PainPainNeuropathic PainNCT00976534AstraZeneca90
终止
2 期
Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the KneePainNCT00878501AstraZeneca241
已完成
1 期
AZD9496 First Time in Patients Ascending Dose StudyER+ HER2- Advanced Breast CancerNCT02248090AstraZeneca45