Evaluation of Four Different Dosing Regimens of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Cross-Linked Polyelectrolyte (CLP)
- Registration Number
- NCT02079233
- Lead Sponsor
- Sorbent Therapeutics
- Brief Summary
This is a study to determine the effect of four different dosing regimens of CLP in normal healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CLP 15 g QD Cross-Linked Polyelectrolyte (CLP) Cross-Linked Polyelectrolyte (CLP) study medication delivered immediately before bedtime CLP 7.5 g BID Cross-Linked Polyelectrolyte (CLP) Cross-Linked Polyelectrolyte (CLP) Study medication delivered b.i.d. one hour before breakfast and dinner CLP 5 g TID Cross-Linked Polyelectrolyte (CLP) Cross-Linked Polyelectrolyte (CLP) Study medication delivered t.i.d. one hour before breakfast, lunch and dinner CLP 3.75 g QID Cross-Linked Polyelectrolyte (CLP) Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d on hour before breakfast, lunch, dinner and immediately before bedtime
- Primary Outcome Measures
Name Time Method Change in fecal sodium content 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.
- Secondary Outcome Measures
Name Time Method