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

Phase 1

Completed

• Conditions: Basic Science: Safety, Tolerability, Efficacy of CLP
• Interventions: Drug: Cross-Linked Polyelectrolyte (CLP)

• Registration Number: NCT01944007
• Lead Sponsor: Sorbent Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-03
• Status Verified: 2013-09
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-16
• Last Update Submitted: 2013-09-16
• Study First Posted: 2013-09-17
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLP 15 g Fed	Cross-Linked Polyelectrolyte (CLP)	Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack
CLP 25 g Fed	Cross-Linked Polyelectrolyte (CLP)	Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack
CLP 7.5 g Fed	Cross-Linked Polyelectrolyte (CLP)	Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack
CLP 15 g fasted	Cross-Linked Polyelectrolyte (CLP)	Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d 1 hour prior to 4 standardized meals/snack

Primary Outcome Measures

Name	Time	Method
Net Sodium Balance	Days 5 - 9	Daily net sodium balance was calculated based on dietary and fluid intake, urinary and fecal output and emesis.

Secondary Outcome Measures

Name	Time	Method
Urine content and concentration of sodium, potassium, magnesium, calcium, and phosphorous	Days 5-9
Total Fecal Weight	Days 1-9	Total fecal weight throughout 9-day treatment period, and mean fecal weights (daily avg. of Days 5-9)
Net Balance of Potassium, Magnesium, Calcium, and Phosphorous	Days 5-9	The net balance of cations was calculated based on dietary and fluid intake, urinary and fecal output, and emesis.
Fecal content and concentration of sodium, potassium, magnesium, calcium, phosphorous, iron, zinc, and copper	Days 5-9
Serum concentrations of sodium, potassium, magnesium, calcium, and phosphorous	Days 5-9

Trial Locations

Locations (1)

Jasper Clinic, Inc.; 🇺🇸 Kalamazoo, Michigan, United States