[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569968":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":35,"locations":26,"responsibleParty":41,"collaborators":26,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":26,"overallStatus":64,"whyStopped":26,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":26},{"fullName":5,"class":6},"Shanghai Jiatan Pharmatech Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sudapyridine (WX-081) Alone","EXPERIMENTAL","Participants will receive Sudapyridine (WX-081) tablets orally at a specified dose once daily for 10 days (in Study A and Study B) or once under fasting and fed conditions (in Study C). Pharmacokinetic sampling and safety assessments will be conducted.",[13],"Drug: Sudapyridine",{"label":15,"type":10,"description":16,"interventionNames":17},"Sudapyridine (WX-081) Combined with Itraconazole or Rifampin","Participants will receive Sudapyridine (WX-081) tablets orally at a specified dose once daily for 7 days while co-administered with itraconazole (Study A) or rifampin (Study B). Pharmacokinetic sampling and safety assessments will be conducted.",[13,18,19],"Drug: Itraconazole","Drug: Rifampin",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sudapyridine","In Study A, Cycle 1 (D1-D10): Participants will take Sudapyridine (WX-081) 300 mg once daily after breakfast. Cycle 2 (D11-D14): Participants will take Sudapyridine 300 mg once daily after breakfast with itraconazole 200 mg daily; an additional itraconazole dose (200 mg) will be given after dinner on D11. In Study B, Cycle 1 (D1): Participants will take Sudapyridine 450 mg as a single dose after breakfast. Cycle 2 (D22): Participants will take Sudapyridine 450 mg with rifampin 600 mg daily (D15-D27). In Study C, Cycle 1 (D1): Sudapyridine 450 mg will be given fasting; Cycle 2 (D15): after a high-fat breakfast.",[9,15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Itraconazole","In Study A: Participants will receive itraconazole capsules at 200 mg orally once daily after breakfast during Cycle 2 (D11-D14). An additional dose of itraconazole (200 mg) will be administered after dinner on D11.",[15],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Rifampin","In Study B: Participants will receive rifampin capsules at 600 mg orally once daily under fasting conditions during Cycle 2 (D15-D27).",[15],[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Li Xiao Jiao, M.D.","CONTACT","+86-0431-88782013","xingxingsuo123456@126.com",{"type":42,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100569968","phase-1-drug-drug-interaction-and-food-effect-of-sudapyridinewx-081-with-itraconazole-and-rifampin-in-healthy-chinese-adults-100569968",false,"NCT06701136","Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults","A Clinical Study to Evaluate the Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) Tablet With Itraconazole and Rifampin in Healthy Chinese Adult Volunteers","WX081-DDI","Inclusion Criteria:\n\n* Participants must be healthy male or female adults of Chinese nationality, aged 18-50 years (including 18 and 50).\n\nMale participants must weigh at least 50 kg, and female participants at least 45 kg. Body mass index (BMI) should be between 18 and 28 kg\u002Fm² (including 18 and 28), and weight (kg)\u002Fheight (m²).\n\nParticipants must undergo a comprehensive physical examination, 12-lead ECG, vital signs assessment, and laboratory tests. Results must be normal or deemed clinically insignificant by the investigator, meeting the following:\n\n12-lead ECG must show QTcF ≤ 450 ms (≤ 200 ms for A Study), QRS duration ≤ 120 ms, and PR interval ≤ 200 ms. PR elongation may allow entry if deemed clinically insignificant by the investigator.\n\nParticipants (including their partners) must agree to use effective contraception from the date of screening to 6 months after the last study drug administration and must avoid sperm\u002Fegg donation during this period.\n\nExclusion Criteria:\n\n* Participants with central nervous system, cardiovascular, gastrointestinal, urinary, respiratory, musculoskeletal, endocrine, or hematologic diseases or other chronic\u002Facute diseases, or those with significant surgical history affecting drug absorption, distribution, metabolism, or excretion.\n\nParticipants with conditions that increase the risk of QT prolongation, or with a family history of sudden cardiac death (\\\u003C40 years old) or other hereditary diseases.\n\nClinically significant laboratory abnormalities at screening, including:\n\nALT\u002FAST\u002FTBIL values exceeding 2 times the upper limit of normal. Estimated creatinine clearance (ClCr) \\\u003C 60 mL\u002Fmin. Participants with urinary system disorders. Use of any prescription or over-the-counter drugs, supplements, or herbal products within 2 weeks before dosing that may affect the study evaluation.\n\nKnown allergy to Sudapyridine (WX-081) or other related compounds. Participants positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibody (Anti-HCV), anti-HIV antibody, or syphilis antibody.\n\nHistory of alcohol or drug abuse:\n\nAlcohol: ≥14 units per week; a unit equals 285 mL beer or 100 mL wine. Participants who smoke more than 5 cigarettes\u002Fday and cannot stop during the study.\n\nDonation of blood exceeding 400 mL within 1 month prior to the study. Participants enrolled in other drug trials within 3 months before the study. Use of CYP3A4 or P-gp inhibitors\u002Finducers within 28 days prior to the study (e.g., itraconazole, rifampin).\n\nUnwillingness to avoid grapefruit, pomelo, or other food\u002Fdrinks affecting drug metabolism during the study.\n\nParticipants with a history of intestinal surgery affecting drug absorption. Women who are pregnant or lactating or intending to become pregnant. Participants deemed unsuitable by the investigator due to other reasons.",true,"ALL","18 Years","50 Years",{"count":56,"type":57},16,"ESTIMATED","INTERVENTIONAL",[60],"PHASE1","The goal of this clinical trial is to learn how Sudapyridine (WX-081) tablets interact with other drugs and how food intake affects its pharmacokinetics in healthy Chinese adults. The main questions it aims to answer are:\n\nHow does itraconazole (a strong CYP3A inhibitor) affect the pharmacokinetics of Sudapyridine? How does rifampin (a strong CYP3A inducer) affect the pharmacokinetics of Sudapyridine? How does food intake influence the pharmacokinetics of Sudapyridine?\n\nParticipants will:\n\nTake Sudapyridine alone, with itraconazole, with rifampin, and under fed and fasting conditions based on a predefined sequence.\n\nAttend multiple clinic visits for blood sample collection and safety evaluations.\n\nResearchers will compare the pharmacokinetic parameters of Sudapyridine under these conditions to determine the impact of drug-drug interactions and food.",[63],"Rifampicin-Resistant Pulmonary Tuberculosis Patients","NOT_YET_RECRUITING","2025-02-10",{"date":67,"type":68},"2025-02-12","ACTUAL",{"date":70,"type":57},"2025-05-12",{"date":72,"type":57},"2026-02-12",{"name":5,"class":6}]