Evaluation of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
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
1 other identifier
interventional
25
1 country
1
Brief Summary
This is a dose-escalation study to determine the effect of CLP in normal healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
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
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 12, 2013
CompletedFirst Posted
Study publicly available on registry
September 17, 2013
CompletedSeptember 17, 2013
September 1, 2013
3 months
September 12, 2013
September 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Net Sodium Balance
Daily net sodium balance was calculated based on dietary and fluid intake, urinary and fecal output and emesis.
Days 5 - 9
Secondary Outcomes (5)
Total Fecal Weight
Days 1-9
Net Balance of Potassium, Magnesium, Calcium, and Phosphorous
Days 5-9
Fecal content and concentration of sodium, potassium, magnesium, calcium, phosphorous, iron, zinc, and copper
Days 5-9
Urine content and concentration of sodium, potassium, magnesium, calcium, and phosphorous
Days 5-9
Serum concentrations of sodium, potassium, magnesium, calcium, and phosphorous
Days 5-9
Study Arms (4)
CLP 15 g Fed
EXPERIMENTALCross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack
CLP 25 g Fed
EXPERIMENTALCross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack
CLP 7.5 g Fed
EXPERIMENTALCross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack
CLP 15 g fasted
EXPERIMENTALCross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d 1 hour prior to 4 standardized meals/snack
Interventions
CLP was administered orally, in capsules, for 9 consecutive days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States
Related Publications (1)
Henderson LW, Dittrich HC, Strickland A, Blok TM, Newman R, Oliphant T, Albrecht D. A Phase 1 dose-ranging study examining the effects of a superabsorbent polymer (CLP) on fluid, sodium and potassium excretion in healthy subjects. BMC Pharmacol Toxicol. 2014 Jan 25;15:2. doi: 10.1186/2050-6511-15-2.
PMID: 24460668DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Blok, MD
Jasper Clinic, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2013
First Posted
September 17, 2013
Study Start
December 1, 2007
Primary Completion
March 1, 2008
Last Updated
September 17, 2013
Record last verified: 2013-09