NCT00984477已完成1 期
A Phase I, Exploratory Study to Assess the Pharmacokinetics of Single Oral Doses and a Single Intravenous Radiolabelled Microtracer Dose of AZD5122 in 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
- 100
- 试验地点
- 1
- 主要终点
- Pharmacokinetic profile: concentration of AZD5122 in blood
研究概览
简要总结
The purpose of the study is to determine how quickly AZD5122 is absorbed into and cleared by the body when given to healthy, non smoking males at different dose levels. This is a 2 part study, in Part B a single group of subjects will be given both an oral dose and intravenous microdose of AZD5122 at a specialist unit. For part B there is no placebo treatment given.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated, written informed consent.
- •Normal physical examination, laboratory values, blood pressure and pulse
- •Healthy male caucasian subjects
排除标准
- •Subjects must not have any history of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body.
- •Subjects must not have abnormal blood or urine tests for hsCRP, circulating neutrophils, haematocrit, haemoglobin or renal function
- •Subjects must not have crystals or more than a trace of blood in their urine
研究组 & 干预措施
3
Experimental
AZD5122 oral and IV infusion (part B)
干预措施: AZD5122 (Drug)
1
Experimental
AZD5122 oral suspension (part A and B)
干预措施: AZD5122 (Drug)
2
Placebo Comparator
Placebo oral suspension (part A)
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetic profile: concentration of AZD5122 in blood
时间窗: Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
次要结局
- Pharmacokinetic profile: concentration of AZD5122 in urine(Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.)
- Pharmacodynamic profile: assessment of various pharmacodynamic measures(Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose.)
- Measurement of the effect of AZD5122 on circulating neutrophils(Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
An Open Label, Single Centre Mass Balance C14 Study in Patients With Acute Myeloid Leukaemia (AML)Acute Myeloid LeukaemiaNCT01019161AstraZeneca5
已完成
1 期
To Study the Absorption, Distribution, Metabolism and Excretion of AZD1305HealthyNCT00689247AstraZeneca10
已完成
1 期
Renal Impairment StudyRefluxRenal ExcretionNCT00863161AstraZeneca23
已完成
1 期
Phase I Study to Assess Absorption, Metabolism & Excretion of a Single Oral Dose [14C]AZD0530 in Healthy Male VolunteersHealthyNCT00853983AstraZeneca6
已完成
1 期
A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD5423 When Administered in Different WaysBioavailability and AUCNCT01635985AstraZeneca18