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

March 4, 2014 updated by: Sorbent Therapeutics

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

This is a study to determine the effect of four different dosing regimens of CLP in normal healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fecal sodium content
Time Frame: Baseline (Days 3-6) vs. Treatment (Days 10-13)
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)

Collaborators and Investigators

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

Sponsor

Sorbent Therapeutics

Investigators

  • Principal Investigator: Shanthini A. Daniel, MD, Jasper Clinic, Inc.

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

May 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Estimate)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTST-16

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.

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