Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT06066060
Status:
COMPLETED
Last Update Posted:
2024-04-25
First Post:
2023-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A DDI Study of JMKX000623 and Metformin Hydrochloride
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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': '2023-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-09-30', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Dosing Time Curve During the Dosing Interval After Reaching Steady State（AUC0-tau）', 'timeFrame': 'baseline through 4 days post-dose'}, {'measure': 'Maximum observed After Reaching steady state concentration (Css,max)', 'timeFrame': 'baseline through 4 days post-dose'}], 'secondaryOutcomes': [{'measure': 'Adverse events (AEs)', 'timeFrame': 'baseline through 4 days post-dose', 'description': 'Incidence and features of AEs assessed by CTCAE v5.0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Drug-Drug Interaction']}, 'descriptionModule': {'briefSummary': 'A phase 1, single center, 1 sequence, 3 period, open label, multiple doses study to evaluate the drug-drug interaction of JMKX000623 tablet and metformin.', 'detailedDescription': 'The drug-drug interaction study is meant to evaluate the pharmacokinetics and safety of JMKX000623 tablet combined metformin in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy Chinese subjects aged 18-45 years, male or female;\n2. Weight: male≥50.0kg, female≥45.0kg, 19.0 kg/m2≤BMI\\<27.0 kg/m2;\n3. Normal or abnormal but without clinical significance reports of physical examinations, vital signs, clinical laboratory tests and others;\n4. Able to provide written informed consent voluntarily.\n\nExclusion Criteria:\n\n1. Suspected hypersensitivity to the main ingredients and excipients of JMKX000623 tablets, metformin hydrochloride tablets, or a history of allergy to drugs, food or other substances;\n2. History of clinically significant chronic gastrointestinal disease or history of gastrointestinal surgery (excluding appendectomy) that the investigator believes may affect drug absorption;\n3. Surgery within 3 months prior to screening that, in the judgment of the investigator, would interfere with the absorption, distribution, metabolism, or excretion of the drug, or surgery within 4 weeks prior to the use of the investigational drug, or planned surgery during the research;\n4. Took any prescription, over-the-counter, and herbal medications within 2 weeks prior to screening, or were within 5 half-lives of the medication at the time of screening, and plan to take other experimental medications other than those in this study for the duration of the research;\n5. Other conditions unsuitable for the study confirmed by the investigator.'}, 'identificationModule': {'nctId': 'NCT06066060', 'briefTitle': 'A DDI Study of JMKX000623 and Metformin Hydrochloride', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jemincare'}, 'officialTitle': 'Phase I Study to Evaluate the Drug-Drug Interaction (DDI) Between JMKX000623 Tablets and Metformin Hydrochloride Tablets in Healthy Chinese Subjects', 'orgStudyIdInfo': {'id': 'JY-JM025-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JMKX000623/Metformin/ JMKX000623+Metformin', 'description': 'D1-D8, JMKX000623; D14-D19, Metformin; D20-D27, JMKX000623+Metformin', 'interventionNames': ['Drug: JMKX000623', 'Drug: Metformin']}], 'interventions': [{'name': 'JMKX000623', 'type': 'DRUG', 'description': 'JMKX000623, administered orally ;', 'armGroupLabels': ['JMKX000623/Metformin/ JMKX000623+Metformin']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin,administered orally', 'armGroupLabels': ['JMKX000623/Metformin/ JMKX000623+Metformin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xiaojie Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jemincare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}