[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562311":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":38,"locations":44,"responsibleParty":64,"collaborators":24,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":24,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":24,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":89,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HDM1002 with Repaglinide, Atorvastatin, Digoxin and Rosuvastatin","EXPERIMENTAL","Period 1: Single dose of repaglinide, atorvastatin, digoxin and rosuvastatin\n\nPeriod 2: Once daily dose of HDM1002\n\nPeriod 3: Single dose of repaglinide, atorvastatin, digoxin and rosuvastatin with once daily dose of HDM1002",[13,14,15,16,17],"Drug: Repaglinide","Drug: Atorvastatin","Drug: Digoxin","Drug: Rosuvastatin","Drug: HDM1002",[19,25,28,31,34],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Repaglinide","Single dose; Administered orally",[9],null,{"type":20,"name":26,"description":22,"armGroupLabels":27,"otherNames":24},"Atorvastatin",[9],{"type":20,"name":29,"description":22,"armGroupLabels":30,"otherNames":24},"Digoxin",[9],{"type":20,"name":32,"description":22,"armGroupLabels":33,"otherNames":24},"Rosuvastatin",[9],{"type":20,"name":35,"description":36,"armGroupLabels":37,"otherNames":24},"HDM1002","Administered orally",[9],[39],{"name":40,"role":41,"phone":42,"phoneExt":24,"email":43},"Cheng Cui","CONTACT","+86-010 82266455","cuicheng1226@163.com",[45],{"facility":46,"status":24,"city":47,"state":24,"zip":24,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Peking University Third Hospital","Beijing","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57,60,62],{"name":58,"role":59,"phone":24,"phoneExt":24,"email":24},"Cui Cheng","PRINCIPAL_INVESTIGATOR",{"name":61,"role":59,"phone":24,"phoneExt":24,"email":24},"Dongyang Liu",{"name":63,"role":59,"phone":24,"phoneExt":24,"email":24},"Xiaohong Wang",{"type":65,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100562311","phase-1-a-drug-drug-interaction-ddi-study-of-hdm1002-with-repaglinide-atorvastatin-digoxin-and-rosuvastatin-in-healthy-subjects-and-overweight-subjects-100562311",false,"NCT06601517","A Drug-Drug Interaction (DDI) Study of HDM1002 With Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy Subjects and Overweight Subjects.","A Phase I, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Effect of Repeated Administration of HDM1002 on the Pharmacokinetics of Repaglinide, Atorvastatin, Digoxin and Rosuvastatin in Healthy and Overweight Adult Chinese Subjects","Inclusion Criteria:\n\n1. According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.\n2. Age range of 18-45 years old (including range), no limit to gender.\n3. Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg\u002Fm2 (including cut-off values).\n\nExclusion Criteria:\n\n1. Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng\u002FL during the screening period.\n2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.\n3. History of acute cholecystitis attack within 3 months prior to screening.\n4. Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.\n5. History of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period.\n6. During screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant .\n7. Taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug.\n8. History of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission.\n9. Presence of clinically significant ECG results judged by the investigator at screening.",true,"ALL","18 Years","45 Years",{"count":78,"type":79},30,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","The purpose of this study is to characterize the effect of HDM1002 on the PK of single dose of repaglinide, atorvastatin, digoxin and rosuvastatin in healthy adult subjects. The safety and tolerability of HDM1002 with repaglinide, atorvastatin, digoxin and rosuvastatin when given separately or together will also be evaluated.",[85,86],"Healthy Adult Subject","Overweight Subject",[35,88],"Glucagon-Like Peptide-1 Receptor Agonists","NOT_YET_RECRUITING","2024-09-19",{"date":92,"type":93},"2024-09-23","ACTUAL",{"date":95,"type":79},"2024-10",{"date":97,"type":79},"2025-04",{"name":5,"class":6},1]