[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635279":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":50,"responsibleParty":67,"collaborators":26,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":96,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"MindRank AI Ltd","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A (Rifampin Arm)","EXPERIMENTAL","Participants receive a single oral dose of MDR-001 alone on Day 1. then rifampin from Day 3 to Day 11, with a second single dose of MDR-001 co-administered on Day 10.",[13,14],"Drug: MDR-001","Drug: Rifampin",{"label":16,"type":10,"description":17,"interventionNames":18},"Part B (Itraconazole Arm)","Participants receive a single oral dose of MDR-001alone on Day 1. , then receive itraconazole once daily from Day 3 to Day 8, with a second single dose of MDR-001 co-administered on Day 7.",[13,19],"Drug: Itraconazole",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","MDR-001","Oral small-molecule GLP-1 receptor agonist ;Investigational drug (not yet approved)",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Rifampin","Strong CYP3A4 inducer; Marketed anti-tuberculosis drug",[9],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Itraconazole","Strong CYP3A4 inhibitor; Marketed antifungal drug",[16],[36],{"name":37,"affiliation":38,"role":39},"Xiaojiao Li, MD","The First Hospital of Jilin University","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Guodong Li, PhD","CONTACT","+8618968027256","guodong.li@mindrank.cn",{"name":47,"role":43,"phone":48,"phoneExt":26,"email":49},"Adam A. H. Baidoo, MD","+8615658610670","adam@mindrank.cn",[51],{"facility":38,"status":26,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Changchun","Jilin","130021","China","CN",{"type":58,"coordinates":59},"Point",[60,61],125.32278,43.88,{"lat":61,"lon":60},[64],{"name":37,"role":43,"phone":65,"phoneExt":26,"email":66},"+8613514314089","xingxingsuo12345@126.com",{"type":68,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100635279","phase-1-drug-drug-interaction-study-of-mdr-001-with-rifampin-and-itraconazole-in-healthy-adult-participants-100635279",false,"NCT07550621","Drug-Drug Interaction Study of MDR-001 With Rifampin and Itraconazole in Healthy Adult Participants","A Phase 1 Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of MDR-001 and the Effect of Itraconazole on the Pharmacokinetics of MDR-001 in Healthy Adult Study Participants","Inclusion Criteria:\n\n* Voluntary participation and signed informed consent before any study procedures, with full understanding of the study content, procedures, and potential adverse reactions.\n* Healthy Chinese adult males or females aged 18 to 55 years (inclusive).\n* Body weight ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) between 18 and 28 kg\u002Fm² (inclusive).\n* Judged by the investigator to be in good health, with medical history, laboratory tests, physical examination, vital signs, and ECG results being normal or abnormal without clinical significance.\n* Participants and their partners must have no pregnancy plan and agree to use effective non-drug contraceptive measures (e.g., condoms, non-medicated intrauterine devices) from 2 weeks before screening until 6 months after the end of the study, unless permanent sterilization has been performed (e.g., bilateral tubal ligation, vasectomy).\n* Willing to comply with the visit schedule, study treatment, laboratory tests, and other study-related procedures and requirements as specified in the protocol.\n\nExclusion Criteria:\n\n* Average daily smoking \\>5 cigarettes within 3 months before dosing.\n* History of headaches (e.g., migraine, tension-type headache).\n* Allergic constitution (multiple drug or food allergies) or intolerance\u002Fallergy to the active ingredient or excipients of the study drugs.\n* History of alcohol abuse (≥14 units of alcohol per week; 1 unit = 285 mL beer, 25 mL spirits, or 100 mL wine).\n* History of drug abuse or use of illicit drugs within 5 years before dosing.\n* Blood donation or significant blood loss (≥400 mL) within 3 months before dosing, or planned blood donation during the study.\n* Any disease that increases bleeding risk, such as acute gastritis or gastric\u002Fduodenal ulcer.\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or genetic conditions predisposing to MTC.\n* History of pancreatitis or symptomatic gallbladder disease.\n* Serum calcitonin \\> upper limit of normal (ULN) at screening.\n* Dysphagia, or gastrointestinal disorders affecting absorption (e.g., diarrhea, vomiting, inflammatory bowel disease, active ulcer), or history of gastrointestinal surgery leading to malabsorption, or long-term use of drugs affecting gastrointestinal motility (e.g., bariatric surgery such as gastric banding).\n* Special dietary requirements and unable to accept standardized meals.\n* Surgery within 3 months before dosing, or planned surgery during the study, or surgery that affects drug absorption, distribution, metabolism, or excretion.\n* Received live attenuated vaccine within 1 month before dosing, or planned vaccination during the study.\n* Use of any prescription drug, over-the-counter drug, vitamin product, or herbal medicine within 14 days before dosing.\n* Significant changes in diet or exercise habits within 3 months before dosing.\n* Use of CYP3A4 inhibitors, CYP3A4 inducers, or P-gp inhibitors within 14 days before the first dose, or planned use during the study.\n* Participation in another clinical trial or receipt of an investigational drug within 3 months before dosing (unless the participant withdrew before treatment\u002Frandomization).\n* ECG abnormalities with clinical significance at screening; QTcF \\>450 msec (males) or \\>470 msec (females) by Fridericia's correction.\n* Pregnant, lactating, or positive pregnancy test in females of childbearing potential.\n* Clinically significant laboratory abnormalities, or clinically significant diseases within 12 months before dosing (respiratory, circulatory, digestive, endocrine, rheumatic\u002Fimmune, nervous, hematologic, or psychiatric disorders) that make the participant unsuitable for the study.\n* Positive screening for hepatitis B surface antigen, hepatitis C antibody\u002Fcore antigen, HIV antibody, or syphilis antibody.\n* Acute illness or concomitant medication between screening and first dose.\n* Positive alcohol breath test or urine drug screen.\n* Any other condition judged by the investigator as unsuitable for participation.",true,"ALL","18 Years","55 Years",{"count":81,"type":82},28,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","A Phase I, open-label, fixed-sequence, two-part drug-drug interaction study in healthy Chinese adults to evaluate the effect of multiple-dose rifampin (Part A) or itraconazole (Part B) on the single-dose pharmacokinetics of MDR-001, an oral GLP-1 receptor agonist.",[88],"Healthy Volunteers (HV)",[23,90,91,28,32,92,93,94,95],"GLP-1 receptor agonist","Drug-drug interaction (DDI)","CYP3A4 inducer","CYP3A4 inhibitor","Pharmacokinetics (PK)","Healthy volunteers","NOT_YET_RECRUITING","2026-04-19",{"date":99,"type":100},"2026-04-24","ACTUAL",{"date":102,"type":82},"2026-05-06",{"date":104,"type":82},"2026-06-08",{"name":5,"class":6},1]