NCT01348724已完成1 期
A Phase I, Open-Label, Single-Centre Study to Assess Absorption, Distribution, Metabolism and Excretion (ADME) After [14C]-Labelled Oral Administration of NKTR-118 to Healthy Male 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
- Percentage of radioactive dose recovered in urine and feces samples and the total percentage of radioactive dose recovered in both urine and feces
研究概览
简要总结
Study to Assess the Absorption, Metabolism and Excretion of [14C] NKTR-118 after a Single-Dose Oral Administration.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 50 Years（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 a minimum weight of 50 kg
- •Regular daily bowel movements (ie, production of at least 1 stool per day).
- •Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥3 months prior to Visit 1
排除标准
- •Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of >5 mSv in the last year, >10 mSv in 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 screening visit 1
- •Excessive intake of caffeine containing drinks e.g., coffee, tea, caffeine containing energy drinks and cola (more than 5 cups of coffee or equivalent per day
研究组 & 干预措施
[14C] NKTR-118
Experimental
干预措施: [14C] NKTR-118 (Drug)
结局指标
主要结局
Percentage of radioactive dose recovered in urine and feces samples and the total percentage of radioactive dose recovered in both urine and feces
时间窗: Range of Day 1 until day 10
Concentration of total radioactivity in blood and plasma samples
时间窗: Range of Day 1 until day 10
Concentration of NKTR-118 in blood and plasma sample
时间窗: Range of Day 1 until day 10
次要结局
- Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing safety blood samples(Range of Day -1 until follow up visit (Visit 3))
- Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing adverse event(Range of Day -1 until follow up visit (Visit 3))
- Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing vital signs(Range of Day -1 until follow up visit (Visit 3))
研究者
研究点 (1)
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