NCT02079233

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

March 3, 2014

Last Update Submit

March 4, 2014

Conditions

Healthy

Keywords

Basic ScienceSafetyTolerabilityEfficacy of CLP

Outcome Measures

Primary Outcomes (1)

  • Change in fecal sodium content

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

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

Study Arms (4)

CLP 15 g QD

EXPERIMENTAL

Cross-Linked Polyelectrolyte (CLP) study medication delivered immediately before bedtime

Drug: Cross-Linked Polyelectrolyte (CLP)

CLP 7.5 g BID

EXPERIMENTAL

Cross-Linked Polyelectrolyte (CLP) Study medication delivered b.i.d. one hour before breakfast and dinner

Drug: Cross-Linked Polyelectrolyte (CLP)

CLP 5 g TID

EXPERIMENTAL

Cross-Linked Polyelectrolyte (CLP) Study medication delivered t.i.d. one hour before breakfast, lunch and dinner

Drug: Cross-Linked Polyelectrolyte (CLP)

CLP 3.75 g QID

EXPERIMENTAL

Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d on hour before breakfast, lunch, dinner and immediately before bedtime

Drug: Cross-Linked Polyelectrolyte (CLP)

Interventions

Cross-Linked Polyelectrolyte (CLP)DRUG

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

CLP 15 g QDCLP 3.75 g QIDCLP 5 g TIDCLP 7.5 g BID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Shanthini A. Daniel, MD

    Jasper Clinic, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 5, 2014

Study Start

May 1, 2010

Primary Completion

July 1, 2010

Last Updated

March 5, 2014

Record last verified: 2014-03