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

Phase 1CompletedNCT02079233

Sorbent Therapeutics25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Cross-Linked Polyelectrolyte (CLP)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in fecal sodium content

The primary endpoint was sodium removal from the stool compared between the Baseline period and the Treatment Period.

Time frame: Baseline (Days 3-6) vs. Treatment (Days 10-13)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.