A Single-center Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Mean change from baseline to ZS treatment period in urine potassium excretion.
研究概览
简要总结
This is a single center, inpatient, open label pharmacodynamic study to determine the effect of 5 g and 10 g doses of Sodium Zirconium Cyclosilicate (ZS) administered once daily (qd) for 4 days on potassium and sodium excretion in healthy Chinese subjects on a standardized, low sodium and high potassium diet.
详细描述
This study will be conducted at 1 study centre in Hong Kong. Approximately 22 Subjects will be screened to achieve 20 subjects completing the study. Subjects will be randomized to receive ZS 5 g or 10 g (1:1) once daily (qd) in conjunction with breakfast and will be continued with a standard diet during the ZS treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Female and/or male healthy Chinese subjects aged between 18 and 55 inclusive who reside in Hong Kong
- •Ability to have repeated blood draws or effective venous catheterization
- •Willing to consume food and beverages using a standardized daily diet containing 40 (± 10%) mEq/day sodium and 128 (± 10%) mEq/day potassium provided by the research site
排除标准
- •Participation in another clinical study with an investigational product during the last 3 months
- •Subjects who were receiving concomitant medications including vitamins, dietary supplements and herbal preparations within 2 weeks prior to Study Day 1 of the Diet Run-in Period.
- •Current and/or past history of alcohol abuse within the past year or a positive results (exceed normal range) of breath test for alcohol abuse
- •Current and/or past history of drugs abuse within the past year or a positive drug abuse screen, e. g. methylenedioxymethamphetamine, opiate, barbiturates, benzodiazepines, ketamine, cocaine, amphetamine, methamphetamine, marijuana, and methadone.
- •Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening.
研究组 & 干预措施
ZS 5g, qd
Subjects randomized to this arm will receive ZS 5 g qd in conjunction with breakfast during the ZS treatment period and will be continued with a standard diet.
干预措施: Sodium Zirconium Cyclosilicate (ZS) (Drug)
ZS 10g, qd
Subjects randomized to this arm will receive ZS 10 g qd in conjunction with breakfast during the ZS treatment period and will be continued with a standard diet.
干预措施: Sodium Zirconium Cyclosilicate (ZS) (Drug)
结局指标
主要结局
Mean change from baseline to ZS treatment period in urine potassium excretion.
时间窗: Study Day 3 and 4 vs Study Day 7 and 8.
The 48- hour urine potassium excretion on Study Days 3 and 4 (baseline) will be compared with 48-hour urine potassium excretion on Study Days 7 and 8 (on study drug).
次要结局
- Mean change from baseline to ZS treatment period in urine sodium excretion.(Study Day 3 and 4 vs Study Day 7 and 8.)
- Mean change from baseline to ZS treatment period in serum potassium (S-K).(Study Day 3 and 4 vs Study Day 7 and 8.)