[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658901":3},{"organization":4,"outcomesModule":7,"designInfo":15,"detailedDescription":11,"studyPopulation":11,"armGroups":21,"interventions":28,"overallOfficials":11,"centralContacts":33,"locations":11,"responsibleParty":39,"collaborators":11,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":11,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":11,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":11,"overallStatus":61,"whyStopped":11,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":11},{"fullName":5,"class":6},"Chendu DIAO Pharmaceutical Group CO., LTD.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Total recovery of HDM1002 radioactivity in urine and feces, following oral administration of [14C] DA-302168S",null,"Predose up to Day 8 after administration of [14C]DA-302168S",{"measure":14,"description":11,"timeFrame":12},"Identification of Major Metabolites in Human Plasma, Urine, and Feces",{"allocation":16,"interventionModel":17,"interventionModelDescription":11,"primaryPurpose":18,"observationalModel":11,"timePerspective":11,"maskingInfo":19},"NA","SINGLE_GROUP","TREATMENT",{"masking":20,"maskingDescription":11,"whoMasked":11},"NONE",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"[14C] DA-302168S","EXPERIMENTAL","A single dose of HDM1002 and \\[14C\\] DA-302168S administered orally.",[27],"Drug: [14C] DA-302168S",[29],{"type":30,"name":23,"description":31,"armGroupLabels":32,"otherNames":11},"DRUG","Administered orally",[23],[34],{"name":35,"role":36,"phone":37,"phoneExt":11,"email":38},"qin xiaolong","CONTACT","18781997925","qinxiaolong.cn@outlook.com",{"type":40,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658901","phase-1-mass-balance-study-of-14cda-302168s-in-healthy-chinese-adult-male-participants-100658901",false,"NCT07857265","Mass Balance Study of [14C]DA-302168S in Healthy Chinese Adult Male Participants","A Clinical Study on the Mass Balance of [14C]DA-302168S in Healthy Adult Male Trial Participants in China","Inclusion Criteria:\n\n\\- Male participants aged 18-55 years inclusive at ICF signing.\n\nAt screening, weight ≥50.0 kg and BMI 19.0-28.0 kg\u002Fm² inclusive.\n\nMale participants must agree to use reliable contraception for themselves and their partners during the study and for 1 year after dosing (see Appendix 2), and not donate sperm for assisted reproduction.\n\nAble to understand the study procedures and methods, voluntarily sign the ICF, and willing to strictly comply with the protocol and complete the study.\n\nDetailed medical history, physical examination, vital signs, laboratory tests \\[CBC, blood chemistry, coagulation, urinalysis, stool routine and occult blood, thyroid function (FT3, FT4, TSH), HbA1c, amylase, lipase, serum calcitonin\\], 12-lead ECG, chest X-ray (PA), digital rectal examination, and abdominal ultrasound (liver, gallbladder, pancreas, spleen, both kidneys) show no abnormalities or no clinically significant abnormalities.\n\nExclusion Criteria:\n\n* History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or MEN2; or serum calcitonin ≥50 ng\u002FL at screening.\n\nHistory of chronic pancreatitis, or acute pancreatitis within 3 months before ICF signing.\n\nHistory of acute gallbladder disease within 3 months before ICF signing.\n\nAny malignancy within 5 years before ICF signing (except basal cell carcinoma treated with curative therapy and considered cured).\n\nHistory of serious cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, or endocrine disease within 1 year before ICF signing (e.g., acute myocardial infarction, major depression, gastric ulcer, uremia).\n\nAs judged by the investigator, dysphagia at screening, or concurrent conditions that may affect drug absorption, distribution, metabolism, or excretion, such as active inflammatory bowel disease, gastrectomy, or any intestinal resection.\n\nSevere hypoglycemia within 3 months before screening.\n\nHistory of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis), or known intolerance or allergy to GLP-1R agonists.\n\nHemorrhoids, or perianal disease with regular\u002Fcurrent hematochezia, irritable bowel syndrome, or inflammatory bowel disease.\n\nHabitual constipation or diarrhea.\n\nBlood donation or major bleeding (≥400 mL) within 3 months before screening, or between screening and first dose.\n\nHistory of drug abuse within 3 years before screening (e.g., morphine, ketamine, THC acid, methamphetamine, MDA, cocaine), or positive urine drug test at screening (D-2).\n\nSmoking \\>5 cigarettes\u002Fday or habitual use of nicotine-containing products within 3 months before screening, and unable to abstain during the study.\n\nHistory of alcohol abuse within 1 year before screening (male: \\>14 standard units\u002Fweek; 1 unit = 14 g alcohol, e.g., 360 mL beer, 45 mL 40% spirits, or 150 mL wine), or positive alcohol breath\u002Fblood test at screening.\n\nSpecial dietary requirements and unable to accept the standardized diet.\n\nHabitual intake of grapefruit juice or excessive tea, coffee, and\u002For caffeinated beverages (\\>8 cups, 1 cup = 250 mL) within 3 months before screening, and unable to abstain during the study.\n\nUnable to avoid strenuous exercise or other behaviors that may affect PK parameters from 48 h before dosing through the entire study.\n\nHistory of needle or blood phobia, difficult blood collection, or intolerance to venipuncture.\n\nUse of any medication within 28 days or 5 elimination half-lives before first dose, whichever is longer, including prescription drugs, OTC drugs, herbal medicines, Chinese patent medicines, or nutritional supplements.\n\nLive vaccination within 1 month before screening, or planned vaccination during the study.\n\nParticipation in any clinical trial within 3 months before screening (except ICF signing only without drug\u002Fdevice intervention), or last dose of investigational drug \\\u003C5 half-lives before screening.\n\nOccupational long-term radiation exposure; or significant radiation exposure within 1 year before the study (e.g., ≥2 chest\u002Fabdominal CT scans or ≥3 other types of X-ray examinations); or planned radiological diagnosis\u002Ftreatment within 1 year after the study; or participation in a clinical trial involving radiolabeled drugs within 1 year.\n\nAny other condition that, in the investigator's opinion, makes the participant unsuitable for the trial.",true,"MALE","18 Years","55 Years",{"count":53,"type":54},10,"ESTIMATED","INTERVENTIONAL",[57],"PHASE1","In this study, a single dose of \\[14C\\] radiolabelled DA-302168S will be administered orally. The main purpose of this study is to find out how much of DA-302168S and its metabolites pass from blood into urine and feces, and characterize the metabolic profile and routes of excretion of oral \\[14C\\] DA-302168S.",[60],"Healthy Adult Subjects","NOT_YET_RECRUITING","2026-09-29",{"date":64,"type":65},"2026-10-05","ACTUAL",{"date":67,"type":54},"2026-11-20",{"date":69,"type":54},"2026-12-20",{"name":5,"class":6}]