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

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ClinicalTrials.gov Identifier: NCT01944007
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : September 17, 2013
Sponsor:
Information provided by (Responsible Party):
Sorbent Therapeutics

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

Condition or disease Intervention/treatment Phase
Basic Science: Safety, Tolerability, Efficacy of CLP Drug: Cross-Linked Polyelectrolyte (CLP) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : December 2007
Actual Primary Completion Date : March 2008

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. Fecal content and concentration of sodium, potassium, magnesium, calcium, phosphorous, iron, zinc, and copper [ Time Frame: Days 5-9 ]
  4. Urine content and concentration of sodium, potassium, magnesium, calcium, and phosphorous [ Time Frame: Days 5-9 ]
  5. Serum concentrations of sodium, potassium, magnesium, calcium, and phosphorous [ Time Frame: Days 5-9 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01944007


Locations
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United States, Michigan
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States
Sponsors and Collaborators
Sorbent Therapeutics
Investigators
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Principal Investigator: Thomas Blok, MD Jasper Clinic, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sorbent Therapeutics
ClinicalTrials.gov Identifier: NCT01944007     History of Changes
Other Study ID Numbers: CTST-5
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013
Keywords provided by Sorbent Therapeutics:
CLP