Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-24 @ 7:09 PM
Study NCT ID:
NCT03818295
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2019-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-18', 'studyFirstSubmitDate': '2019-01-24', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of total radioactivity excreted in urine (Aeu) and feces (Aef)', 'timeFrame': 'up to Day 15'}, {'measure': 'Cumulative Aeu and cumulative Aef', 'timeFrame': 'up to Day 15'}, {'measure': 'Percentage of total radioactivity excreted in urine (feu) and feces (fef)', 'timeFrame': 'up to Day 15'}, {'measure': 'Cumulative feu and cumulative fef', 'timeFrame': 'up to Day 15'}, {'measure': 'Percentage of total radioactivity in total excreta (feces + urine)', 'timeFrame': 'up to Day 15'}, {'measure': 'Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of praliciguat in plasma', 'timeFrame': 'up to Day 15'}, {'measure': 'AUC0-inf of total radioactivity in plasma and whole blood', 'timeFrame': 'up to Day 15'}, {'measure': 'AUC from time zero to the last quantifiable concentration (AUC0-last) of praliciguat in plasma', 'timeFrame': 'up to Day 15'}, {'measure': 'AUC0-last of total radioactivity in plasma and whole blood', 'timeFrame': 'up to Day 15'}, {'measure': 'Maximum observed concentration (Cmax) of praliciguat in plasma', 'timeFrame': 'up to Day 15'}, {'measure': 'Cmax of total radioactivity in plasma and whole blood', 'timeFrame': 'up to Day 15'}, {'measure': 'Time of Cmax (Tmax) of praliciguat in plasma', 'timeFrame': 'up to Day 15'}, {'measure': 'Tmax of total radioactivity in plasma and whole blood', 'timeFrame': 'up to Day 15'}, {'measure': 'Apparent terminal elimination half-life (t1/2) of praliciguat in plasma', 'timeFrame': 'up to Day 15'}, {'measure': 't1/2 total radioactivity in plasma and whole blood', 'timeFrame': 'up to Day 15'}, {'measure': 'Apparent total clearance of praliciguat (CL/F)', 'timeFrame': 'up to Day 15'}, {'measure': 'Apparent volume of distribution of praliciguat (Vz/F)', 'timeFrame': 'up to Day 15'}, {'measure': 'AUC0-inf of plasma praliciguat concentration relative to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Plasma Praliciguat/Plasma Total Radioactivity)', 'timeFrame': 'up to Day 15'}, {'measure': 'AUC0-inf of whole blood total radioactivity to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Blood Total Radioactivity/Plasma Total Radioactivity)', 'timeFrame': 'up to Day 15'}], 'secondaryOutcomes': [{'measure': 'Levels of metabolite radioactivity excreted in urine and feces', 'timeFrame': 'up to Day 15'}, {'measure': 'AUC0-inf of metabolite radioactivity levels in plasma', 'timeFrame': 'up to Day 15'}, {'measure': 'AUC0-inf of plasma metabolite radioactivity levels relative to AUC0-inf of plasma total radioactivity (Plasma AUC0-inf Ratio of Metabolite Radioactivity/Total Radioactivity)', 'timeFrame': 'up to Day 15'}, {'measure': 'Chromatographic retention time of metabolites', 'timeFrame': 'up to Day 15'}, {'measure': 'Molecular ion mass of metabolites', 'timeFrame': 'up to Day 15'}, {'measure': 'Characteristic mass spectrometry fragmentation ions of metabolites', 'timeFrame': 'up to Day 15'}, {'measure': 'Chemical structures (graphical representations showing atom connectivity) proposed for plasma, urine, and feces metabolites', 'timeFrame': 'up to Day 15'}, {'measure': 'Number(s) of participants with ≥1 treatment-emergent serious adverse event (SAE)', 'timeFrame': 'up to Day 15'}, {'measure': 'Number(s) of participants with ≥1 adverse event (AE) leading to study drug discontinuation', 'timeFrame': 'up to Day 15'}, {'measure': 'Number(s) of participants with ≥1 Grade ≥3 AE (per CTCAE v. 5.0)', 'timeFrame': 'up to Day 15'}, {'measure': 'Number(s) of participants with ≥1 clinically significant abnormal physical examination finding', 'timeFrame': 'up to Day 15'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The primary objective is to characterize the pharmacokinetics (PK) of praliciguat and total radioactivity and to assess the elimination of total radioactivity from a single oral dose of \\[14C\\]-praliciguat.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males of any race, between 18 and 55 years of age, inclusive\n* Body mass index between 18 and 32 kg/m2, inclusive\n* Subject is in good health and has no clinically significant findings on physical examination\n* Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for at least 90 days after the final dose of study drug\n\nExclusion Criteria:\n\n* Any active or unstable clinically significant medical condition\n* Use of any prescribed or non-prescribed medication\n\nAdditional inclusion/exclusion criteria may apply per protocol'}, 'identificationModule': {'nctId': 'NCT03818295', 'briefTitle': 'A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Praliciguat in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cyclerion Therapeutics'}, 'officialTitle': 'A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Praliciguat ([14C]-IW-1973) Following a Single Oral Dose in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'PRL-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Male Volunteers', 'description': 'Single oral dose of \\[14C\\]-praliciguat', 'interventionNames': ['Drug: [14C]-praliciguat']}], 'interventions': [{'name': '[14C]-praliciguat', 'type': 'DRUG', 'otherNames': ['[14C]-IW-1973'], 'description': '10 mg praliciguat containing approximately 500 μCi of \\[14C\\]-praliciguat', 'armGroupLabels': ['Healthy Male Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance Clinical Research Unit Inc.', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'John Hanrahan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ironwood Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cyclerion Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}