Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-05 @ 2:07 PM
Study NCT ID:
NCT02079233
Status:
COMPLETED
Last Update Posted:
2014-03-05
First Post:
2014-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Four Different Dosing Regimens of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-03-04', 'studyFirstSubmitDate': '2014-03-03', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fecal sodium content', 'timeFrame': 'Baseline (Days 3-6) vs. Treatment (Days 10-13)', 'description': 'The primary endpoint was sodium removal from the stool compared between the Baseline period and the Treatment Period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Basic Science', 'Safety', 'Tolerability', 'Efficacy of CLP'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a study to determine the effect of four different dosing regimens of CLP in normal healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer is ≥ 18 years of age with BMI of 18-32\n* Females could not be pregnant or breast feeding and had to be using birth control\n* Must have regular bowel habits, typically producing at least 1 daily bowel movement\n\nExclusion Criteria:\n\n* 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\n* History or presence of gastrointestinal conditions\n* Positive drug screen for substances of abuse\n* Positive results for HIV, hepatitis B, or hepatitis C'}, 'identificationModule': {'nctId': 'NCT02079233', 'briefTitle': 'Evaluation of Four Different Dosing Regimens of Cross-Linked Polyelectrolyte (CLP) in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sorbent Therapeutics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CTST-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CLP 15 g QD', 'description': 'Cross-Linked Polyelectrolyte (CLP) study medication delivered immediately before bedtime', 'interventionNames': ['Drug: Cross-Linked Polyelectrolyte (CLP)']}, {'type': 'EXPERIMENTAL', 'label': 'CLP 7.5 g BID', 'description': 'Cross-Linked Polyelectrolyte (CLP) Study medication delivered b.i.d. one hour before breakfast and dinner', 'interventionNames': ['Drug: Cross-Linked Polyelectrolyte (CLP)']}, {'type': 'EXPERIMENTAL', 'label': 'CLP 5 g TID', 'description': 'Cross-Linked Polyelectrolyte (CLP) Study medication delivered t.i.d. one hour before breakfast, lunch and dinner', 'interventionNames': ['Drug: Cross-Linked Polyelectrolyte (CLP)']}, {'type': 'EXPERIMENTAL', 'label': 'CLP 3.75 g QID', 'description': 'Cross-Linked Polyelectrolyte (CLP) Study medication delivered q.i.d on hour before breakfast, lunch, dinner and immediately before bedtime', 'interventionNames': ['Drug: Cross-Linked Polyelectrolyte (CLP)']}], 'interventions': [{'name': 'Cross-Linked Polyelectrolyte (CLP)', 'type': 'DRUG', 'description': 'CLP was administered orally, in capsules, for 7 consecutive days.', 'armGroupLabels': ['CLP 15 g QD', 'CLP 3.75 g QID', 'CLP 5 g TID', 'CLP 7.5 g BID']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shanthini A. Daniel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jasper Clinic, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorbent Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}