Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-02-27 @ 8:52 AM
Study NCT ID:
NCT03499106
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2018-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631485', 'term': 'praliciguat'}, {'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2018-04-09', 'studyFirstSubmitQcDate': '2018-04-13', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Time Curve of IW-1973 From Time Zero Extrapolated to Infinity (AUC[0-inf])', 'timeFrame': 'Predose and up to 14 days post dose of IW-1973'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of IW-1973', 'timeFrame': 'Predose and up to 14 days post dose of IW-1973'}], 'secondaryOutcomes': [{'measure': 'Time to Cmax (Tmax) of IW-1973', 'timeFrame': 'Predose and up to 14 days post dose of IW-1973'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero to 24 hours AUC(0-24) Postdose of IW-1973', 'timeFrame': 'Predose and up to 14 days post dose of IW-1973'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-last]) of IW-1973', 'timeFrame': 'Predose and up to 14 days post dose of IW-1973'}, {'measure': 'Apparent Terminal Half-Life (t1/2) of IW-1973', 'timeFrame': 'Predose and up to 14 days post dose of IW-1973'}, {'measure': 'Apparent Terminal Rate Constant (lambda[z]) of IW-1973', 'timeFrame': 'Predose and up to 14 days post dose of IW-1973'}, {'measure': 'Apparent Total Plasma Clearance (CL/F) of IW-1973', 'timeFrame': 'Predose and up to 14 days post dose of IW-1973'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of IW-1973', 'timeFrame': 'Predose and up to 14 days post dose of IW-1973'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the effect of itraconazole (a potent cytochrome P450 isoenzyme \\[CYP\\]3A inhibitor) on the pharmacokinetics of IW-1973.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is an ambulatory adult between 18 and 75 years old at the screening visit\n* Subject is in good health and has no clinically significant findings on physical examination\n* Body mass index is \\> 18 and \\< 30.0 kg/m2 at the screening visit\n* Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 2 months after the final dose of study drug\n* Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 2 months after the final dose of study drug\n* Other inclusion criteria per protocol\n\nExclusion Criteria:\n\n* Any active or unstable clinically significant medical condition\n* Use of any prescribed or non-prescribed medication\n* Other exclusion criteria per protocol'}, 'identificationModule': {'nctId': 'NCT03499106', 'briefTitle': 'A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of Praliciguat (IW-1973) in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cyclerion Therapeutics'}, 'officialTitle': 'An Open-label, 2-Period, Fixed-sequence, Phase 1 Study in Healthy Volunteers to Evaluate the Effect of Itraconazole, a Potent CYP3A Inhibitor, on the Pharmacokinetics of IW-1973', 'orgStudyIdInfo': {'id': 'C1973-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteers', 'description': 'Period 1: Single dose of IW-1973. Period 2: ITZ is dosed once daily (QD) for 17 days; a single dose of IW-1973 is administered 1 hour after the fourth ITZ QD dose.', 'interventionNames': ['Drug: IW-1973', 'Drug: Itraconazole']}], 'interventions': [{'name': 'IW-1973', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Healthy Volunteers']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Oral Capsule', 'armGroupLabels': ['Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'IQVIA', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cyclerion Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}