Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT06162169
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2023-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D004077', 'term': 'Digoxin'}, {'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': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2023-11-29', 'studyFirstSubmitQcDate': '2023-12-06', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observed maximum concentrations (Cmax )of JAB-21822', 'timeFrame': 'approximately 10 days'}, {'measure': 'Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of JAB-21822', 'timeFrame': 'approximately 10 days'}, {'measure': 'Area under the concentration versus time curve from dose to infinity (AUC0-∞) of JAB-21822', 'timeFrame': 'approximately 10 days'}, {'measure': 'Observed maximum concentrations (Cmax )of midazolam, rosuvastatin, and digoxin', 'timeFrame': 'approximately 10 days'}, {'measure': 'Area under the concentration versus time curve from dose to the last quantifiable concentration (AUC0-t) of midazolam, rosuvastatin, and digoxin', 'timeFrame': 'approximately 10 days'}, {'measure': 'Area under the concentration versus time curve from dose to infinity (AUC0-∞) of midazolam, rosuvastatin, and digoxin', 'timeFrame': 'approximately 10 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This is a phase I study to evaluate drug-drug interactions (DDIs) of JAB-21822 as a perpetrator combined with midazolam , rosuvastatin, and digoxin and to evaluate DDIs of JAB-21822 as a victim combined with itraconazole， rifampicin， and omeprazole in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female ；Healthy subjects aged 18 to 50 years (including both ends) at the time of signing informed consent\n2. Male subjects weighed ≥50kg, female subjects weighed ≥45kg, body mass index (BMI) was between 19.0 and 26.0kg/m2, BMI= weight (kg)/height 2 (m2), including boundary values.\n3. Subjects voluntarily signed written informed consent and were able to communicate well with the investigator\n\nExclusion Criteria:\n\n1. History of severe systemic diseases, history of liver and kidney insufficiency, history of mental illness, history of drug dependence;\n2. Patients with a history of interstitial pneumonia, pulmonary fibrosis or other interstitial lung diseases who were not eligible for admission by the investigators;\n3. Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, and have digestive diseases (such as peptic ulcer, pancreatitis, colitis, etc.) within 3 months before the first dose;\n4. The investigator believes that the subject has any other circumstances that make him or her unfit to participate in this clinical trial'}, 'identificationModule': {'nctId': 'NCT06162169', 'briefTitle': 'A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allist Pharmaceuticals, Inc.'}, 'officialTitle': 'A Single-center, Non-randomized, Open-lable, Self-controlled Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects', 'orgStudyIdInfo': {'id': 'JAB-21822-1010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JAB-21822+Itraconazole', 'interventionNames': ['Drug: JAB-21822', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'JAB-21822+ Rifampicin', 'interventionNames': ['Drug: JAB-21822', 'Drug: Rifampicin']}, {'type': 'EXPERIMENTAL', 'label': 'JAB-21822+ Omeprazole', 'interventionNames': ['Drug: JAB-21822', 'Drug: Omeprazole']}, {'type': 'EXPERIMENTAL', 'label': 'Dazolam , Rosuvastatin calcium and digoxin with JAB-21822', 'interventionNames': ['Drug: JAB-21822', 'Drug: Midazolam , Rosuvastatin calcium and digoxin']}], 'interventions': [{'name': 'JAB-21822', 'type': 'DRUG', 'description': 'JAB-21822 was administered orally', 'armGroupLabels': ['Dazolam , Rosuvastatin calcium and digoxin with JAB-21822', 'JAB-21822+ Omeprazole', 'JAB-21822+ Rifampicin', 'JAB-21822+Itraconazole']}, {'name': 'Itraconazole', 'type': 'DRUG', 'description': 'Itraconazole was administered orally', 'armGroupLabels': ['JAB-21822+Itraconazole']}, {'name': 'Omeprazole', 'type': 'DRUG', 'description': 'Omeprazole was administered orally', 'armGroupLabels': ['JAB-21822+ Omeprazole']}, {'name': 'Midazolam , Rosuvastatin calcium and digoxin', 'type': 'DRUG', 'description': 'Midazolam , Rosuvastatin calcium and digoxin was administered orally', 'armGroupLabels': ['Dazolam , Rosuvastatin calcium and digoxin with JAB-21822']}, {'name': 'Rifampicin', 'type': 'DRUG', 'description': 'Rifampicin was administered orally', 'armGroupLabels': ['JAB-21822+ Rifampicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102206', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing GoBroad Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'He Qing B.Pharm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Gaobo Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allist Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}