NCT02176252已完成1 期
A Phase I, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects in Healthy Male and Female Japanese Subjects After Single and Multiple Doses (Bid) of AZD1722
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
- Ardelyx
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
The study is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7 days in order to allow for including Japanese subjects in future global studies. A cohort of Caucasian subjects will be included in the study to evaluate cardiac effects, assessed by digital ECGs (dECG) recordings, also in Caucasian subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy man or woman
- •Body mass index between 18 and 29.9 kg/m2, inclusive
排除标准
- •Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gastrointestinal (GI) tract
- •Any surgery on the small intestine or colon, excluding appendectomy
- •Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial or that would present a safety risk to the subject.
研究组 & 干预措施
AZD1722
Experimental
Dose escalation from 5 mg to 90 mg BID
干预措施: AZD1722 (Drug)
AZD1722
Experimental
Dose escalation from 5 mg to 90 mg BID
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: up to 3 weeks
Measurement of safety laboratories, ECGs, vital signs, and physical exams
次要结局
- pharmacodynamic activity(up to one week)
- pharmacokinetics(up to one week)
研究者
研究点 (1)
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