Evaluation of Four Different Dosing Regimens of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a study to determine the effect of four different dosing regimens of CLP in normal healthy volunteers.

Official Title
-----------------
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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Cross-Linked Polyelectrolyte (CLP)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLP 15 g QD<br>Cross-Linked Polyelectrolyte (CLP) study medication delivered immediately before bedtime | Drug: Cross-Linked Polyelectrolyte (CLP)<br>* CLP was administered orally, in capsules, for 7 consecutive days.<br>|
| Experimental: CLP 7.5 g BID<br>Cross-Linked Polyelectrolyte (CLP) Study medication delivered b.i.d. one hour before breakfast and dinner | Drug: Cross-Linked Polyelectrolyte (CLP)<br>* CLP was administered orally, in capsules, for 7 consecutive days.<br>|
| Experimental: CLP 5 g TID<br>Cross-Linked Polyelectrolyte (CLP) Study medication delivered t.i.d. one hour before breakfast, lunch and dinner | Drug: Cross-Linked Polyelectrolyte (CLP)<br>* CLP was administered orally, in capsules, for 7 consecutive days.<br>|
| Experimental: CLP 3.75 g QID<br>Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d on hour before breakfast, lunch, dinner and immediately before bedtime | Drug: Cross-Linked Polyelectrolyte (CLP)<br>* CLP was administered orally, in capsules, for 7 consecutive days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fecal sodium content | The primary endpoint was sodium removal from the stool compared between the Baseline period and the Treatment Period. | Baseline (Days 3-6) vs. Treatment (Days 10-13) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Basic Science, Safety, Tolerability, Efficacy of CLP