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

Phase 1CompletedNCT01944007

Sorbent Therapeutics25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Basic Science: Safety, Tolerability, Efficacy of CLP

Interventions

Cross-Linked Polyelectrolyte (CLP)DRUG

CLP was administered orally, in capsules, for 9 consecutive days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Jasper Clinic, Inc.

Kalamazoo, Michigan, United States

Outcomes

Primary Outcomes

Net Sodium Balance

Daily net sodium balance was calculated based on dietary and fluid intake, urinary and fecal output and emesis.

Time frame: Days 5 - 9

Secondary Outcomes

Total Fecal Weight

Total fecal weight throughout 9-day treatment period, and mean fecal weights (daily avg. of Days 5-9)

Time frame: 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.

Time frame: Days 5-9

Fecal content and concentration of sodium, potassium, magnesium, calcium, phosphorous, iron, zinc, and copper

Time frame: Days 5-9

Urine content and concentration of sodium, potassium, magnesium, calcium, and phosphorous

Time frame: Days 5-9

Serum concentrations of sodium, potassium, magnesium, calcium, and phosphorous

Time frame: Days 5-9

Data from ClinicalTrials.gov

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