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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02079233

Enrollment

Registered

2014-03-05

Start date

2010-05-31

Completion date

Unknown

Last updated

2014-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Basic Science, Safety, Tolerability, Efficacy of CLP

Brief summary

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

Interventions

DRUGCross-Linked Polyelectrolyte (CLP)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in fecal sodium content	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026