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OpenTrials
Completed

NCT Number: NCT01944007

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

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

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Key information

Conditions

Basic Science: Safety, Tolerability, Efficacy of CLP

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jasper Clinic, Inc.

Kalamazoo, Michigan, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cross-Linked Polyelectrolyte (CLP)

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sorbent Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
First posted
Sep 17, 2013
Registry last updated
Sep 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.