Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT07229560
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum concentration (Cmax) of HRS-8080.', 'timeFrame': 'From Day 1 to Day 11.'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast) of HRS-8080.', 'timeFrame': 'From Day 1 to Day 11.'}, {'measure': 'Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of HRS-8080.', 'timeFrame': 'From Day 1 to Day 11.'}], 'secondaryOutcomes': [{'measure': 'Time to maximum plasma concentration (Tmax) of HRS-8080.', 'timeFrame': 'From Day 1 to Day 11.'}, {'measure': 'Terminal elimination half-life (t1/2) of HRS-8080.', 'timeFrame': 'From Day 1 to Day 11.'}, {'measure': 'Apparent volume of distribution (Vz/F) of HRS-8080.', 'timeFrame': 'From Day 1 to Day 11.'}, {'measure': 'Clearance (CL/F) of HRS-8080.', 'timeFrame': 'From Day 1 to Day 11.'}, {'measure': 'Adverse events (AEs).', 'timeFrame': 'From Day 1 to Day 17.'}, {'measure': 'Serious adverse events (SAEs).', 'timeFrame': 'From Day 1 to Day 17.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase I study to evaluate the effect of Itraconazole on the pharmacokinetics of HRS-8080 in healthy participants and the safety of HRS-8080 administered alone and in combination with Itraconazole in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-55 years;\n2. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-28 kg/m2;\n3. Normal or no clinically significant medical history, ECGs, vital signs and laboratory tests;\n4. Take contraception.\n\nExclusion Criteria:\n\n1. Any serious clinical diseases or medical history or diseases that affect the absorption, metabolism and/or excretion of the study drug;\n2. Severe infection, severe trauma or major surgery;\n3. Any medications in the two weeks before screening or baseline period;\n4. History of blood donation or severe blood loss;\n5. Have been vaccinated within 3 months before the screening or baseline period;\n6. History of smoking or excessive alcohol or drug abuse;\n7. History of excessive amounts of tea, coffee or caffeinated beverages, special foods; or have special dietary requirements;\n8. Other situations in which the researcher judges unsuitable.'}, 'identificationModule': {'nctId': 'NCT07229560', 'briefTitle': 'A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Suncadia Medicine Co., Ltd.'}, 'officialTitle': 'The Effect of Itraconazole on the Pharmacokinetics of Orally Administered HRS-8080 in Healthy Participants: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study', 'orgStudyIdInfo': {'id': 'HRS-8080-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRS-8080 Tablets and Itraconazole Capsules Group', 'interventionNames': ['Drug: HRS-8080 Tablet', 'Drug: Itraconazole Capsule']}], 'interventions': [{'name': 'HRS-8080 Tablet', 'type': 'DRUG', 'description': 'HRS-8080 tablet, specified dose on specified days.', 'armGroupLabels': ['HRS-8080 Tablets and Itraconazole Capsules Group']}, {'name': 'Itraconazole Capsule', 'type': 'DRUG', 'description': 'Itraconazole capsule, specified dose on specified days.', 'armGroupLabels': ['HRS-8080 Tablets and Itraconazole Capsules Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}