Phase 1 Multiple Dose Trial to Assess the Safety, Tolerability and Efficacy of Four Different Dosing Regimens of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Change in fecal sodium content
研究概览
简要总结
This is a study to determine the effect of four different dosing regimens 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer is ≥ 18 years of age with BMI of 18-32
- •Females could not be pregnant or breast feeding and had to be using birth control
- •Must have regular bowel habits, typically producing at least 1 daily bowel movement
排除标准
- •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
- •History or presence of gastrointestinal conditions
- •Positive drug screen for substances of abuse
- •Positive results for HIV, hepatitis B, or hepatitis C
研究组 & 干预措施
CLP 3.75 g QID
Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d on hour before breakfast, lunch, dinner and immediately before bedtime
干预措施: Cross-Linked Polyelectrolyte (CLP) (Drug)
CLP 15 g QD
Cross-Linked Polyelectrolyte (CLP) study medication delivered immediately before bedtime
干预措施: Cross-Linked Polyelectrolyte (CLP) (Drug)
CLP 7.5 g BID
Cross-Linked Polyelectrolyte (CLP) Study medication delivered b.i.d. one hour before breakfast and dinner
干预措施: Cross-Linked Polyelectrolyte (CLP) (Drug)
CLP 5 g TID
Cross-Linked Polyelectrolyte (CLP) Study medication delivered t.i.d. one hour before breakfast, lunch and dinner
干预措施: Cross-Linked Polyelectrolyte (CLP) (Drug)
结局指标
主要结局
Change in fecal sodium content
时间窗: Baseline (Days 3-6) vs. Treatment (Days 10-13)
The primary endpoint was sodium removal from the stool compared between the Baseline period and the Treatment Period.
次要结局
未报告次要终点