Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-04-07 @ 1:23 PM
Study NCT ID:
NCT02646358
Status:
COMPLETED
Last Update Posted:
2016-12-22
First Post:
2016-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'lastUpdateSubmitDate': '2016-12-20', 'studyFirstSubmitDate': '2016-01-01', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics variable - Area under the plasma concentration curve', 'timeFrame': 'Time zero through 96 hours'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v.4.03', 'timeFrame': 'Time zero through Day 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics of Vepoloxamer', 'Healthy Volunteers', 'Renal Impaired']}, 'descriptionModule': {'briefSummary': 'This is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Subject must weigh ≤ 125 kg and have a body mass index between 20 and 40 kg/m2\n* Subject must be willing to be confined in the clinical research unit for the duration of the study, up to 5 days\n* If female, subject must not be pregnant or lactating, have a negative pregnancy test, and agrees to sexual abstinence, or use of an appropriate birth control method from screening through 30 days after study drug administration\n* If male, subject agrees to sexual abstinence, is surgically sterile, or is using an appropriate birth control method from screening through 30 days after study drug administration\n* Considered by the Investigator to be healthy or clinically stable with respect to underlying renal impairment based on medical evaluation including vital signs, ECG and laboratory test results\n* Non-smoker, or smokes fewer than 10 cigarettes/day\n\nKey Exclusion Criteria\n\n* Uncontrolled medical condition (treated or untreated) considered to be clinically significant by the Investigator\n* Experienced an illness considered by the Investigator to be clinically significant within 2 weeks of study drug administration\n* Treatment with another investigational drug or device study within 30 days or 5 half-lives (whichever is longer) prior to screening\n* Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1\n* Donated or lost a significant volume of blood or plasma within 90 days prior to study drug administration'}, 'identificationModule': {'nctId': 'NCT02646358', 'briefTitle': 'Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mast Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Vepoloxamer in Subjects With Varying Degrees of Renal Impairment and Healthy Matched Control Subjects With Normal Renal Function', 'orgStudyIdInfo': {'id': 'MST-188-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Normal Renal Function', 'description': 'Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours', 'interventionNames': ['Drug: Vepoloxamer']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Mild Renal Impairment', 'description': 'Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours', 'interventionNames': ['Drug: Vepoloxamer']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: Moderate Renal Impairment', 'description': 'Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours', 'interventionNames': ['Drug: Vepoloxamer']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: Severe Renal Impairment', 'description': 'Vepoloxamer Injection, 100 mg/kg for 1 hour followed by 30 mg/kg/hr for 5 hours', 'interventionNames': ['Drug: Vepoloxamer']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 5: End Stage Renal Disease', 'description': 'Vepoloxamer Injection, 50 mg/kg for 1 hour followed by 15 mg/kg/hr for 5 hours', 'interventionNames': ['Drug: Vepoloxamer']}], 'interventions': [{'name': 'Vepoloxamer', 'type': 'DRUG', 'armGroupLabels': ['Cohort 1: Normal Renal Function', 'Cohort 2: Mild Renal Impairment', 'Cohort 3: Moderate Renal Impairment', 'Cohort 4: Severe Renal Impairment', 'Cohort 5: End Stage Renal Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'DaVita Clinical Research', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'DaVita Clinical Research', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Edwin L Parsley, DO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mast Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mast Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}