Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-27 @ 10:57 AM
Study NCT ID:
NCT05413668
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2022-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent
Sponsor:
Organization:
Raw JSON
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'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RVP-001: 2 mg Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 2 mg Mn/kg administered via automated injection pump.'}, {'id': 'OG001', 'title': 'RVP-001: 4 mg Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 4 mg Mn/kg administered via automated injection pump.'}, {'id': 'OG002', 'title': 'RVP-001: 7 mn Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 7 mg Mn/kg administered via automated injection pump.'}, {'id': 'OG003', 'title': 'RVP-001: 12 mg Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 12 mg Mn/kg administered via automated injection pump.'}], 'classes': [{'categories': [{'measurements': [{'value': '264', 'spread': '21.6', 'groupId': 'OG000'}, {'value': 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'timeFrame': 'pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose', 'description': 'tmax = time of maximum observed plasma concentration of RVP-001', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'PK Parameter t1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RVP-001: 2 mg Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 2 mg Mn/kg administered via automated injection pump.'}, {'id': 'OG001', 'title': 'RVP-001: 4 mg Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 4 mg Mn/kg administered via automated injection pump.'}, {'id': 'OG002', 'title': 'RVP-001: 7 mn Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 7 mg Mn/kg administered via automated injection pump.'}, {'id': 'OG003', 'title': 'RVP-001: 12 mg Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 12 mg Mn/kg administered via automated injection pump.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.718', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '1.765', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '1.613', 'spread': '7.0', 'groupId': 'OG002'}, {'value': '1.839', 'spread': '20.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose', 'description': 't1/2 = terminal elimination half-life of RVP-001', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of RVP-001 and had sufficient data to calculate at least one PK parameter'}, {'type': 'PRIMARY', 'title': 'PK Parameter Cl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RVP-001: 2 mg Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 2 mg Mn/kg administered via automated injection pump.'}, {'id': 'OG001', 'title': 'RVP-001: 4 mg Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 4 mg Mn/kg administered via automated injection pump.'}, {'id': 'OG002', 'title': 'RVP-001: 7 mn Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 7 mg Mn/kg administered via automated injection pump.'}, {'id': 'OG003', 'title': 'RVP-001: 12 mg Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 12 mg Mn/kg administered via automated injection pump.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'spread': '18.8', 'groupId': 'OG000'}, 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'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of RVP-001 and had sufficient data to calculate at least one PK parameter'}, {'type': 'SECONDARY', 'title': '% RVP-001 Dose Excreted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'RVP-001: 2 mg Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 2 mg Mn/kg administered via automated injection pump.'}, {'id': 'OG001', 'title': 'RVP-001: 4 mg Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 4 mg Mn/kg administered via automated injection pump.'}, {'id': 'OG002', 'title': 'RVP-001: 7 mn Mn/kg', 'description': '6 subjects received RVP-001 in a single dose of 7 mg Mn/kg administered via automated 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'BG000', 'lowerLimit': '22', 'upperLimit': '55'}, {'value': '35.3', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '54'}, {'value': '30.3', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '35'}, {'value': '44.3', 'groupId': 'BG003', 'lowerLimit': '32', 'upperLimit': '54'}, {'value': '39.0', 'groupId': 'BG004', 'lowerLimit': '30', 'upperLimit': '52'}, {'value': '38.53', 'groupId': 'BG005', 'lowerLimit': '22', 'upperLimit': '55'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 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'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '72.97', 'groupId': 'BG000', 'lowerLimit': '62.8', 'upperLimit': '96.3'}, {'value': '77.57', 'groupId': 'BG001', 'lowerLimit': '63.5', 'upperLimit': '92.3'}, {'value': '79.00', 'groupId': 'BG002', 'lowerLimit': '58.8', 'upperLimit': '92.8'}, {'value': '76.83', 'groupId': 'BG003', 'lowerLimit': '60.5', 'upperLimit': '90.8'}, {'value': '81.09', 'groupId': 'BG004', 'lowerLimit': '67.7', 'upperLimit': '90.5'}, {'value': '77.72', 'groupId': 'BG005', 'lowerLimit': '58.8', 'upperLimit': '93.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '167.5', 'groupId': 'BG000', 'lowerLimit': '148', 'upperLimit': '186'}, {'value': '169.3', 'groupId': 'BG001', 'lowerLimit': '160', 'upperLimit': '180'}, {'value': '170.8', 'groupId': 'BG002', 'lowerLimit': '160', 'upperLimit': '179'}, {'value': '168.0', 'groupId': 'BG003', 'lowerLimit': '156', 'upperLimit': '182'}, {'value': '171.0', 'groupId': 'BG004', 'lowerLimit': '161', 'upperLimit': '181'}, {'value': '169.4', 'groupId': 'BG005', 'lowerLimit': '148', 'upperLimit': '186'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.03', 'groupId': 'BG000', 'lowerLimit': '22.0', 'upperLimit': '31.1'}, {'value': '26.95', 'groupId': 'BG001', 'lowerLimit': '23.0', 'upperLimit': '30.4'}, {'value': '26.93', 'groupId': 'BG002', 'lowerLimit': '20.8', 'upperLimit': '29.6'}, {'value': '27.08', 'groupId': 'BG003', 'lowerLimit': '24.9', 'upperLimit': '29.3'}, {'value': '27.66', 'groupId': 'BG004', 'lowerLimit': '24.9', 'upperLimit': '30.3'}, {'value': '26.98', 'groupId': 'BG005', 'lowerLimit': '20.8', 'upperLimit': '31.1'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-09', 'size': 12036819, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-22T12:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2022-05-26', 'resultsFirstSubmitDate': '2023-07-22', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-20', 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic (PK) Parameter Cmax', 'timeFrame': 'pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose', 'description': 'Cmax = maximum observed blood plasma concentration of RVP-001'}, {'measure': 'PK Parameter Tmax', 'timeFrame': 'pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose', 'description': 'tmax = time of maximum observed plasma concentration of RVP-001'}, {'measure': 'PK Parameter t1/2', 'timeFrame': 'pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose', 'description': 't1/2 = terminal elimination half-life of RVP-001'}, {'measure': 'PK Parameter Cl', 'timeFrame': 'pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose', 'description': 'Cl = total body clearance calculated after a single IV administration of RVP-001'}, {'measure': 'PK Parameter Vd', 'timeFrame': 'pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose', 'description': 'Vd = volume of distribution calculated after a single IV administration of RVP-001'}], 'secondaryOutcomes': [{'measure': '% RVP-001 Dose Excreted', 'timeFrame': 'pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose', 'description': 'mean % of RVP-001 excreted from urine from 0 -120 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objectives of this trial are:\n\n1. To evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers\n2. To determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.', 'detailedDescription': 'The first in human study is intended to evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers, and to determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects\n2. Healthy subjects aged 18 to 55 years inclusive\n3. Suitable veins for phlebotomy, cannulation, or repeated venipuncture\n4. Have a body mass index between 18 and 32 kg/m\\^2 (inclusive); weigh at least 55 kg.\n5. Appropriately completed written informed consent prior to any study specific procedures.\n\nExclusion Criteria:\n\n1. Any clinically significant abnormality or abnormal laboratory test results found during medical screening\n2. Vital sign abnormalities at screening or admission\n3. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease; neurological or psychiatric disorder, as judged by the investigator\n4. Positive pregnancy test at screening or admission\n5. History of alcohol abuse\n6. History of drug abuse\n7. Use of nicotine-containing products within 12 months of study start\n8. Use of medication except topical products without significant systemic absorption\n9. Known allergies to any component of RVP-001\n10. Subjects who have received any investigational product (IP) in a clinical research study within 5 IP half-lives or 30 days prior to first dose.\n11. Donation of plasma within 7 days prior to dosing; significant donation or loss of blood within 30 days prior to the first dosing.\n12. Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.'}, 'identificationModule': {'nctId': 'NCT05413668', 'briefTitle': 'First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent', 'organization': {'class': 'INDUSTRY', 'fullName': 'Reveal Pharmaceuticals Inc.'}, 'officialTitle': 'A Single Center, Double-Blinded, Phase 1a Randomized Study to Evaluate Safety and Pharmacokinetics of a New Manganese Based Magnetic Resonance Imaging (MRI) Contrast Agent, RVP-001, in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'RVL-101-22'}, 'secondaryIdInfos': [{'id': 'R44CA268392', 'link': 'https://reporter.nih.gov/quickSearch/R44CA268392', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RVP-001 group', 'description': '4 Cohorts of 6 subjects each will receive RVP-001 at doses of 2, 4, 7 and 12 mg Mn/kg.', 'interventionNames': ['Drug: RVP-001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': '4 Cohorts of 2 subjects each will receive placebo (saline).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RVP-001', 'type': 'DRUG', 'otherNames': ['MnPyC3A'], 'description': 'Intravenous administration of RVP-001', 'armGroupLabels': ['RVP-001 group']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['saline'], 'description': 'Intravenous administration of saline placebo', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Quotient Sciences', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Srinivasan Mukundan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Reveal Pharmaceuticals'}, {'name': 'Jeffrey Levy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quotient Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reveal Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Quotient Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}