Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2026-01-06 @ 5:43 AM
Study NCT ID:
NCT06246695
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2024-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Jaktinib in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D012293', 'term': 'Rifampin'}], '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'}, {'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Up to 32 Days', 'description': 'Pharmacokinetics of Jaktinib by assessment of maximum plasma concentration'}, {'measure': 'AUC', 'timeFrame': 'Up to 32 Days', 'description': 'Area under the plasma concentration versus time curve (AUC) of Jaktinib'}, {'measure': 'Adverse Events', 'timeFrame': 'Up to 32 Days', 'description': 'Number of Participants With treatment-related Adverse Events and Serious Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to assess the effect of rifampicin and itraconazole, on the pharmacokinetics (PK) of Jaktinib in healthy Volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteers aged between 18 and 45 years old;\n* Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 28 (including 19 and 28);\n* The participant is in good health and has no history of heart, liver, kidney, digestive tract, nervous system, etc.;\n\nExclusion Criteria:\n\n* The participant were deemed unsuitable for participating in the study by the investigator for any reason.'}, 'identificationModule': {'nctId': 'NCT06246695', 'briefTitle': 'A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Jaktinib in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd'}, 'officialTitle': 'A Study to Evaluate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Jaktinib in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'ZGJAK022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhibitor group', 'description': 'Jaktinib 100mg, once daily on the 1st and 9th days before meal; Itraconazole 200mg, once daily from the 4th day to the 12th day.', 'interventionNames': ['Drug: Jaktinib Hydrochloride Tablets', 'Drug: Itraconazole capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Inducer group', 'description': '1. Jaktinib 100mg, once daily on the 1st and 12th days before meal, Rifampicin 600mg, once daily from the 4th day to the 14th day.\n2. Rifampicin 600mg, once daily from the 1th day to the 11th day, Jaktinib 100mg, once daily on the 9st and 25th days before meal.', 'interventionNames': ['Drug: Jaktinib Hydrochloride Tablets', 'Drug: Rifampicin Capsules']}], 'interventions': [{'name': 'Jaktinib Hydrochloride Tablets', 'type': 'DRUG', 'otherNames': ['Jaktinib'], 'description': 'Oral Jaktinib 100 mg for 1 day', 'armGroupLabels': ['Inducer group', 'Inhibitor group']}, {'name': 'Itraconazole capsule', 'type': 'DRUG', 'otherNames': ['Itraconazole'], 'description': 'Oral Itraconazole 200 mg for 9 day', 'armGroupLabels': ['Inhibitor group']}, {'name': 'Rifampicin Capsules', 'type': 'DRUG', 'otherNames': ['Rifampicin'], 'description': 'Oral Rifampicin 600 mg for 11 day', 'armGroupLabels': ['Inducer group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '233004', 'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Bengbu Medical College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}], 'overallOfficials': [{'name': 'Jason Wu', 'role': 'STUDY_CHAIR', 'affiliation': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}