Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT05437094
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2022-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2022-06-17', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-24 of CRD-740 alone and with coadministration of itraconazole', 'timeFrame': 'Day 1 to Day 16'}, {'measure': 'AUC0-inf of CRD-740 alone and with coadministration of itraconazole', 'timeFrame': 'Day 1 to Day 16'}, {'measure': 'AUC0-t of CRD-740 alone and with coadministration of itraconazole', 'timeFrame': 'Day 1 to Day 16'}, {'measure': 'Cmax of CRD-740 alone and with coadministration of itraconazole', 'timeFrame': 'Day 1 to Day 16'}], 'secondaryOutcomes': [{'measure': 'Half life (t1/2) of CRD-740', 'timeFrame': 'Day 1 to Day 16'}, {'measure': 'Time to maximum concentration (Tmax) of CRD-740', 'timeFrame': 'Day 1 to Day 16'}, {'measure': 'Oral clearance (CL/F) of CRD-740', 'timeFrame': 'Day 1 to Day 16'}, {'measure': 'Apparent volume of distribution during terminal phase (Vz/F) of CRD-740', 'timeFrame': 'Day 1 to Day 16'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Pharmacology', 'Pharmacokinetics', 'Cardiovascular Diseases', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, single-site, open-label, fixed sequence crossover study to investigate the effect of coadministration of itraconazole on the pharmacokinetics of CRD-740 in healthy male and female subjects. Subjects will be admitted into the study site on Day -1 and will be confined to the study site until discharge on Day 16. Subjects will receive CRD-740 orally on Days 1 and 10. Itraconazole will be given once daily, orally, on Days 7 through 15.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males or females, of any race, between 18 and 55 years of age, inclusive.\n2. Body mass index between 18.0 and 32.0 kg/m2, inclusive.\n3. In good health, determined by no clinically significant findings as assessed by the investigator.\n4. Adhere to all contraception criteria.\n\nExclusion Criteria:\n\n1. Significant medical history as determined by the investigator.\n2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including itraconazole, unless approved by the investigator (or designee).\n3. History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).\n4. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator.\n5. History or presence of an abnormal ECG.\n6. Use or intend to use any medications/products/herbal remedies known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee).\n7. Drugs affecting CYP3A4 should be refrained from use for 3 weeks, or 5 half-lives (whichever is longer), prior to check-in through to follow-up.\n8. Positive urine drug screen at screening or positive alcohol breath test result or positive urine drug screen at check-in.21. History of alcoholism or drug/chemical abuse within 12 months prior to check-in.\n9. Ingestion of poppy seed, Seville orange, or grapefruit containing foods or beverages within 7 days prior to check-in."}, 'identificationModule': {'nctId': 'NCT05437094', 'briefTitle': 'Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cardurion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label, Fixed Sequence Study to Investigate the Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'CRD-740-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CRD-740', 'description': 'CRD-740 single dose administered alone', 'interventionNames': ['Drug: CRD-740']}, {'type': 'OTHER', 'label': 'CRD-740 and Itraconazole', 'description': 'CRD-740 single dose administered with Itraconazole', 'interventionNames': ['Drug: CRD-740', 'Drug: Itraconazole']}], 'interventions': [{'name': 'CRD-740', 'type': 'DRUG', 'description': 'CRD-740', 'armGroupLabels': ['CRD-740', 'CRD-740 and Itraconazole']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Itraconazole', 'armGroupLabels': ['CRD-740 and Itraconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Cardurion Investigative Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardurion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}