NCT01223014已完成不适用
An Open Label, Single Dose, Phase I Study to Evaluate the Excretion of Radioactivity, the Metabolic Profile, Pharmacokinetics, Safety and Tolerability Following Single Oral Administration of [14C]AZD2423 to Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Percentage of radioactive dose recovered in urine and faeces and total percentage
研究概览
简要总结
Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C]AZD2423 in healthy male volunteers aged 50 to 65 years (inclusive).The purpose of this study is to investigate how and how quickly AZD 2423 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg
- •Regular daily bowel movements (ie, production of at least 1 stool per day)
- •Provision of signed and dated, written informed consent prior to any study specific procedures
排除标准
- •Healthy volunteers exposed to radiation levels above background (eg, through X ray examination) of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life
- •Participation in any prior radiolabelled study within 12 months of the screening visit (Visit 1)
- •History of alcohol abuse or excessive intake of alcohol defined as regular intake of more than 15 units of alcohol a week. (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer)
研究组 & 干预措施
1
Single cohort of 6 subjects
干预措施: AZD2423 (Drug)
结局指标
主要结局
Percentage of radioactive dose recovered in urine and faeces and total percentage
时间窗: During residential period on Day 8
Concentration of total radioactivity in blood and plasma
时间窗: During residential period on Day 8
次要结局
- Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing concomitant medications(Range of Day -1 until follow up visit (Visit 3))
- Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing haematology(Range of Day -1 until follow up visit (Visit 3))
- Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing urinalysis(Range of Day -1 until follow up visit (Visit 3))
- Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing body weight(Range of Day -1 until follow up visit (Visit 3))
- Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing adverse events(Range of Day -1 until follow up visit (Visit 3))
- Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing clinical chemistry(Range of Day -1 until follow up visit (Visit 3))
- Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing electrocardiogram(Range of Day -1 until follow up visit (Visit 3))
- Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by assessing vital signs(Range of Day -1 until follow up visit (Visit 3))
- Safety and tolerability of AZD2423 following administration of a single oral dose of [C14] AZD2423 solution by physical examination(Range of Day -1 until follow up visit (Visit 3))
研究者
研究点 (1)
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