Evaluation of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
NCT ID: NCT01944007
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CLP 15 g Fed
Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack
Cross-Linked Polyelectrolyte (CLP)
CLP was administered orally, in capsules, for 9 consecutive days.
CLP 25 g Fed
Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack
Cross-Linked Polyelectrolyte (CLP)
CLP was administered orally, in capsules, for 9 consecutive days.
CLP 7.5 g Fed
Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d just before each of 4 standardized meals/snack
Cross-Linked Polyelectrolyte (CLP)
CLP was administered orally, in capsules, for 9 consecutive days.
CLP 15 g fasted
Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d 1 hour prior to 4 standardized meals/snack
Cross-Linked Polyelectrolyte (CLP)
CLP was administered orally, in capsules, for 9 consecutive days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cross-Linked Polyelectrolyte (CLP)
CLP was administered orally, in capsules, for 9 consecutive days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sorbent Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Blok, MD
Role: PRINCIPAL_INVESTIGATOR
Jasper Clinic, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jasper Clinic, Inc.
Kalamazoo, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTST-5
Identifier Type: -
Identifier Source: org_study_id