NCT01318655已完成1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of NKTR-118 Following Single and Multiple Ascending Oral Dose Administration in Healthy Young and Elderly Japanese Subjects, and an Open Randomized, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics After Single Oral Doses of NKTR-118 in Healthy Male Japanese 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
- 50
- 试验地点
- 1
- 主要终点
- Investigate the safety and tolerability of NKTR-118 using incidence of Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with healthy subjects.
详细描述
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of NKTR-118 following single and multiple ascending oral dose administration in healthy young and elderly Japanese subjects, and an Open Randomized, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics after single oral doses of NKTR-118 in healthy male Japanese subjects
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
- None
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
- •20 Years to 45 Years, 65 Years to 80 Years
- •Body mass index (BMI): 18 to 27 kg/m
- •Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.
- •Non-smokers or ex-smokers (not smoked in the past 3 months).
排除标准
- •Clinically relevant disease and/or abnormalities (past or present)
- •Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis as judged by the investigator
- •Use of any prescribed or non-prescribed medication including herbal remedies, vitamins and minerals during the two weeks prior to the first administration of investigational product
研究组 & 干预措施
NKTR-118
Experimental
干预措施: NKTR-118 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Investigate the safety and tolerability of NKTR-118 using incidence of Adverse Events
次要结局
- Assessment of drug concentrations in plasma by characterizing PK parameters (AUC)
- Assessment of drug concentrations in plasma by characterizing PK parameters (Cmax)
研究者
研究点 (1)
Loading locations...
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