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

September 16, 2013 updated by: Sorbent Therapeutics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Kalamazoo, Michigan, United States
        • Jasper Clinic, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net Sodium Balance
Time Frame: Days 5 - 9
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
Time Frame: Days 1-9
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
Time Frame: Days 5-9
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
Time Frame: Days 5-9
Days 5-9
Urine content and concentration of sodium, potassium, magnesium, calcium, and phosphorous
Time Frame: Days 5-9
Days 5-9
Serum concentrations of sodium, potassium, magnesium, calcium, and phosphorous
Time Frame: Days 5-9
Days 5-9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorbent Therapeutics

Investigators

  • Principal Investigator: Thomas Blok, MD, Jasper Clinic, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

March 1, 2008

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (ESTIMATE)

September 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTST-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Basic Science: Safety, Tolerability, Efficacy of CLP

Clinical Trials on Cross-Linked Polyelectrolyte (CLP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe