Evaluation of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers

Study Overview
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Brief Summary
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This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.

Official Title
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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

Conditions
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Basic Science: Safety, Tolerability, Efficacy of CLP

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLP 15 g Fed<br>Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack | Drug: Cross-Linked Polyelectrolyte (CLP)<br>* CLP was administered orally, in capsules, for 9 consecutive days.<br>|
| Experimental: CLP 25 g Fed<br>Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack | Drug: Cross-Linked Polyelectrolyte (CLP)<br>* CLP was administered orally, in capsules, for 9 consecutive days.<br>|
| Experimental: CLP 7.5 g Fed<br>Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack | Drug: Cross-Linked Polyelectrolyte (CLP)<br>* CLP was administered orally, in capsules, for 9 consecutive days.<br>|
| Experimental: CLP 15 g fasted<br>Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d 1 hour prior to 4 standardized meals/snack | Drug: Cross-Linked Polyelectrolyte (CLP)<br>* CLP was administered orally, in capsules, for 9 consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net Sodium Balance | Daily net sodium balance was calculated based on dietary and fluid intake, urinary and fecal output and emesis. | Days 5 - 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Fecal Weight | Total fecal weight throughout 9-day treatment period, and mean fecal weights (daily avg. of Days 5-9) | Days 1-9 | 
| Net Balance of Potassium, Magnesium, Calcium, and Phosphorous | The net balance of cations was calculated based on dietary and fluid intake, urinary and fecal output, and emesis. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CLP