NCT02346890已完成1 期
A Phase 1, Single-center, Randomized, 2-way Crossover, Open Label Study to Evaluate the Effect of Renvela on the Pharmacodynamics of AZD1722 in Healthy Volunteeers
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
- 16
- 试验地点
- 1
- 主要终点
- Sodium levels in stool and urine
研究概览
简要总结
The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy volunteers taking Renvela.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
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 or cholecystectomy or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- •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 alone
Experimental
15 mg BID
干预措施: AZD1722 (Drug)
AD1722 with Renvela
Experimental
AZD1722 15 mg BID and Renvela 800 mg TID
干预措施: AZD1722 (Drug)
AD1722 with Renvela
Experimental
AZD1722 15 mg BID and Renvela 800 mg TID
干预措施: Renvela (Drug)
结局指标
主要结局
Sodium levels in stool and urine
时间窗: 4 days
Pharmacodynamic activity
次要结局
- Evaluate the safety of AZD1722, measured by Adverse events(8 days)
- Evaluate the safety of AZD1722, measured by clinical laboratory changes(8 days)
- Plasma drug concentration to calculate AUC(8 days)
研究者
研究点 (1)
Loading locations...
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