Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-28 @ 11:03 PM
Study NCT ID:
NCT06335134
Status:
COMPLETED
Last Update Posted:
2025-05-08
First Post:
2023-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D014859', 'term': 'Warfarin'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D004077', 'term': 'Digoxin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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': 'D013457', 'term': 'Sulfur Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2023-07-29', 'studyFirstSubmitQcDate': '2024-03-25', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of metformin: AUC0-inf', 'timeFrame': 'up to 101 days'}, {'measure': 'Pharmacokinetics of S-warfarin and R-warfarin: AUC0-inf', 'timeFrame': 'up to 114 days'}, {'measure': 'Pharmacokinetics of rosuvastatin: AUC0-inf', 'timeFrame': 'up to 102 days'}, {'measure': 'Pharmacokinetics of digoxin: AUC0-inf', 'timeFrame': 'up to 112days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ecnoglutide', 'XW003', 'Metformin', 'Warfarin', 'Rosuvastatin', 'Digoxin'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a study of a drug-drug interaction between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin', 'detailedDescription': 'This is a single-center, open-label, fixed-sequence study designed to assess the effect of once-weekly subcutaneous injections of XW003 on the pharmacokinetics of metformin, warfarin, rosuvastatin or digoxin. Approximately 56 healthy subjects are to be enrolled into 2 parallel trial groups, with 28 subjects and 2 drugs evaluated in each of the trial group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, 18-45 years old, inclusive;\n2. BMI: 20.0 to 30.0 kg/m2 , body weight: ≥50.0kg.\n3. Ability and willingness to participate in the study, give written informed consent, and comply with the study requirements and all protocol procedures.\n\nExclusion Criteria:\n\n1. Presence of clinically significant conditions (including but not limited to respiratory system, cardiovascular system, gastrointestinal system, endocrine system, immune system, integumentary system, nervous system, ENT or other related diseases);\n2. History of allergic diseases including asthma, urticaria or eczema, or history of sensitivity to GLP-1 products, digoxin, warfarin, rosuvastatin or metformin;\n3. Known difficulty in swallowing tablets or history of gastrointestinal diseases affecting drug absorption;\n4. History of receiving any procedures that might affect drug absorption, distribution, metabolism or excretion;\n5. History of acute or chronic pancreatitis;\n6. History of documented or suspected hypoglycemic episodes within 6 months prior to screening;'}, 'identificationModule': {'nctId': 'NCT06335134', 'briefTitle': 'A Drug-Drug Interaction Study Between XW003 and Metformin, Warfarin, Rosuvastatin or Digoxin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hangzhou Sciwind Biosciences Co., Ltd.'}, 'officialTitle': 'A Single-Center, Open-Label Study to Evaluate the Effect of XW003 Injection on the Pharmacokinetics of Metformin, Warfarin, Rosuvastatin or Digoxin in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SCW0502-1016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment', 'description': 'Metformin will be dosed twice daily (0.5 mg per dose) in two periods of 3.5 days for a total of 7 doses before and with XW003 treatment. Single doses of warfarin (2.5 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks.', 'interventionNames': ['Drug: XW003 injection', 'Drug: Metformin', 'Drug: Warfarin']}, {'type': 'EXPERIMENTAL', 'label': 'Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment', 'description': 'Single doses of rosuvastatin (10 mg per dose) and digoxin (0.25 mg per dose) will be given before and with XW003 treatment. The two drugs will be separated by a washout. XW003 will be administered subcutaneously once weekly in escalating doses of 0.3 mg for 4 weeks, 0.6 mg for 4 weeks and 1.2 mg for 4 weeks.', 'interventionNames': ['Drug: XW003 injection', 'Drug: Rosuvastatin', 'Drug: Digoxin']}], 'interventions': [{'name': 'XW003 injection', 'type': 'DRUG', 'otherNames': ['ecnoglutide'], 'description': 'Administered subcutaneously', 'armGroupLabels': ['Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment', 'Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Trial Group 1: Metformin and Warfarin administered before and with XW003 treatment']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment']}, {'name': 'Digoxin', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Trial Group 2: Rosuvastatin and Digoxin administered before and with XW003 treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Second University Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Qin Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Second University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou Sciwind Biosciences Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}