[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100412437":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":27,"locations":36,"responsibleParty":60,"collaborators":27,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":27,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":27,"studyType":76,"phases":77,"briefSummary":66,"conditions":79,"keywords":27,"overallStatus":81,"whyStopped":27,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"HUYABIO International, LLC.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HBI-3000 alone (Period 1) followed by HBI-3000 with Paroxetine (Period 2)","EXPERIMENTAL","HBI-3000: 350 mg, 50 mL intravenous infusion (IV) over 30 minutes on Day 1 of Period 1 and approximately 15 days later on Day 1 of Period 2\n\nParoxetine: 20 mg dose twice a day on Days 1 and 2 of Period 2, and once a day on Days 3 through 7 inclusive of Period 2",[13,14],"Drug: HBI-3000","Drug: Paroxetine",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","HBI-3000","small molecule, multi-ion channel blocker",[9],[22],"Sulcardine sulfate",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Paroxetine","serotonin uptake inhibitor, CYP2D6 inhibitor",[9],null,[29,33],{"name":30,"affiliation":31,"role":32},"Jason Lickliter, MD","Nucleus Network","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Jennifer Deering, MSN, ARNP","Spaulding Clinical",[37,49],{"facility":35,"status":27,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":27},"West Bend","Wisconsin","53095","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-88.18343,43.42528,{"lat":47,"lon":46},{"facility":50,"status":27,"city":51,"state":52,"zip":27,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":27},"Nucleus Network Pty Ltd.","Melbourne","Victoria","Australia","AU",{"type":44,"coordinates":56},[57,58],144.96332,-37.814,{"lat":58,"lon":57},{"type":61,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100412437","phase-1-drug-drug-interaction-study-of-hbi-3000-and-paroxetine-in-healthy-adult-male-and-female-subjects-100412437",false,"NCT04650542","Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects","Open-Label, Two-Period Phase 1 Study in Healthy Subjects to Evaluate the Potential Effect of Multiple Doses of Paroxetine on the Pharmacokinetics and Safety of HBI-3000","Inclusion Criteria:\n\nHealthy adult males and females\n\n* 18 - 50 years of age\n* BMI 18 - 32 kg\u002Fm2\n* Subject has no clinically significant abnormality on electrocardiogram (ECG)\n* Subject has been a nonsmoker and\u002For has not used nicotine or nicotine-containing products for at least 4 months\n* Subject is willing to comply with the study restrictions, including contraception requirements\n\nExclusion Criteria:\n\n* Evidence of a clinically significant disease or abnormalities, including an active, current infection or clinically significant infection within 8 weeks prior to the first dose\n* Severe allergic reaction, angioedema, or anaphylaxis to drugs, or food or latex allergies\n* Subject has an estimated creatinine clearance of ≤ 70 mL\n* Subject has evidence of a clinically significant deviation from normal in the physical examination, vital signs, or clinical laboratory determinations\n* Subject has significant ECG abnormality, history or presence of cardiac arrhythmia or conduction abnormalities, or bradycardia (\\\u003C 45 bpm)\n* Subject has a history of vasovagal syncope, or symptomatic orthostatic hypotension\n* Subject has as a history of or current alcohol abuse and\u002For other drug addiction\n* Subject has received an investigational drug (including investigational vaccines) within 5 half-lives of such drug prior to Study Day 1\n* Subject has received CYP2D inhibitors (e.g., fluoxetine, sertraline, duloxetine, bupropion, chloroquine, cimetidine, diphenhydramine) less than 3 weeks prior to administration of the initial dose of study drug\n* Subject has suicidal thinking and behavior (suicidality) or other significant psychiatric disorders based on self-disclosure during interview (Screening visit)\n* Subject has a history of acute narrow-angle glaucoma\n* Subject has as any condition that would make him or her, in the opinion of the Investigator or Sponsor, unsuitable for the study",true,"ALL","18 Years","50 Years",{"count":74,"type":75},39,"ACTUAL","INTERVENTIONAL",[78],"PHASE1",[80],"Drug-drug Interaction","COMPLETED","2022-07-14",{"date":84,"type":75},"2022-07-15",{"date":86,"type":75},"2021-02-21",{"date":88,"type":75},"2021-08-13",{"name":5,"class":6},2]