Open-label Phase 1 Multiple Dose Escalation Trial to Assess the Safety, Tolerability, and Efficacy of Capsules Containing Cross-linked Polyelectrolyte (CLP) Given to Normal Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Net Sodium Balance
研究概览
简要总结
This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females between the ages of 18 and 70 years
- •Body mass index (BMI) between 18 and 32 kg/m^2, inclusive
- •Females could not be pregnant or breast feeding and had to be using birth control
排除标准
- •Positive drug screen for substances of abuse
- •Positive results for HIV, hepatitis B, or hepatitis C
- •Screening 12-lead ECG demonstrating QTc interval >430 msec for males and >450 msec for females, or any cardiac rhythm disorder considered by the Investigator to be clinically relevant
研究组 & 干预措施
CLP 15 g Fed
Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack
干预措施: Cross-Linked Polyelectrolyte (CLP) (Drug)
CLP 25 g Fed
Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack
干预措施: Cross-Linked Polyelectrolyte (CLP) (Drug)
CLP 7.5 g Fed
Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack
干预措施: Cross-Linked Polyelectrolyte (CLP) (Drug)
CLP 15 g fasted
Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d 1 hour prior to 4 standardized meals/snack
干预措施: Cross-Linked Polyelectrolyte (CLP) (Drug)
结局指标
主要结局
Net Sodium Balance
时间窗: Days 5 - 9
Daily net sodium balance was calculated based on dietary and fluid intake, urinary and fecal output and emesis.
次要结局
- Total Fecal Weight(Days 1-9)
- Net Balance of Potassium, Magnesium, Calcium, and Phosphorous(Days 5-9)
- Fecal content and concentration of sodium, potassium, magnesium, calcium, phosphorous, iron, zinc, and copper(Days 5-9)
- Urine content and concentration of sodium, potassium, magnesium, calcium, and phosphorous(Days 5-9)
- Serum concentrations of sodium, potassium, magnesium, calcium, and phosphorous(Days 5-9)