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

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ClinicalTrials.gov Identifier: NCT02079233
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
Sorbent Therapeutics

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Cross-Linked Polyelectrolyte (CLP) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2010
Actual Primary Completion Date : July 2010

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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079233


Sponsors and Collaborators
Sorbent Therapeutics
Investigators
Principal Investigator: Shanthini A. Daniel, MD Jasper Clinic, Inc.

Responsible Party: Sorbent Therapeutics
ClinicalTrials.gov Identifier: NCT02079233     History of Changes
Other Study ID Numbers: CTST-16
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by Sorbent Therapeutics:
Basic Science
Safety
Tolerability
Efficacy of CLP