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OpenTrials
Completed

NCT Number: NCT02079233

Evaluation 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.

Completed

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Cross-Linked Polyelectrolyte (CLP)

Drug

CLP was administered orally, in capsules, for 7 consecutive days.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sorbent Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
First posted
Mar 5, 2014
Registry last updated
Mar 5, 2014

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.

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