[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100224836":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":36,"responsibleParty":49,"collaborators":26,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":26,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},{"fullName":5,"class":6},"Vaxart","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Vapendavir 528 mg QD","EXPERIMENTAL","Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days",[13,14],"Drug: Midazolam 5mg Syrup","Drug: Vapendavir 528 mg QD",{"label":16,"type":10,"description":17,"interventionNames":18},"Vapendavir 264 mg BID","Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.",[13,19],"Drug: Vapendavir 264 mg BID",[21,27,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Midazolam 5mg Syrup","All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.\n\n* On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning.\n* On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B.",[16,9],null,{"type":22,"name":16,"description":17,"armGroupLabels":28,"otherNames":26},[16],{"type":22,"name":9,"description":11,"armGroupLabels":30,"otherNames":26},[9],[32],{"name":33,"affiliation":34,"role":35},"Mark Matson, MD","Prism Clinical Research","PRINCIPAL_INVESTIGATOR",[37],{"facility":34,"status":26,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":26},"Saint Paul","Minnesota","55114","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-93.09327,44.94441,{"lat":47,"lon":46},{"type":50,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100224836","phase-1-a-drug-drug-interaction-study-to-evaluate-the-effect-of-vapendavir-on-the-pharmacokinetics-of-midazolam-in-healthy-male-and-female-volunteers-100224836",false,"NCT02204501","A Drug-Drug Interaction Study to Evaluate the Effect of Vapendavir on the Pharmacokinetics of Midazolam in Healthy Male and Female Volunteers","A Phase 1, Randomized, Open-Label Study to Evaluate the Effect of Vapendavir (BTA798) on the Pharmacokinetics of Orally Administered Midazolam, a CYP3A4 Substrate, in Healthy Male and Female Volunteers","Inclusion Criteria:\n\n* Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg\u002Fm2 (inclusive), and weight ≥50 kg at the time of screening;\n* Capable of giving written informed consent;\n* Subject is able to understand and comply with the protocol requirements, instructions and restrictions;\n* Healthy on the basis of physical examination, medical history, medication usage, vital signs (VS), electrocardiograms (ECGs), and clinical laboratory tests;\n* Female subjects who are not post-menopausal for at least 2 years or surgically sterile with complete hysterectomy or bilateral oophorectomy and male subjects who are not surgically sterile via vasectomy, must agree to use a double barrier method of birth control, such as a condom plus spermicidal agent (foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository); and\n* Female subjects must not be breastfeeding or pregnant.\n\nExclusion Criteria:\n\n* Positive results for Hepatitis B, Hepatitis C, or HIV;\n* Frequent use (defined as \\> 5 times\u002Fday) of tobacco products, including cigarettes, cigars, chewing tobacco;\n* A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event;\n* Current or recent respiratory infection (defined as within 14 days of first study visit participation)\n* Presence or history of significant allergy;\n* Clinically significant abnormalities noted on ECG;\n* Screening vital signs representing sustained elevated systolic blood pressure \\\u003C90 mmHg or \\>140 mmHg, and\u002For diastolic blood pressure \\\u003C55 mmHg or \\>90 mmHg.\n* Presence of significant gastrointestinal abnormalities such as diarrhea or constipation;\n* Safety laboratory abnormalities noted at screening which are clinically significant\n* Current or defined history of abuse of alcohol or illicit drugs;\n* A positive pregnancy test at screening;\n* Poor vein access or fear of venipuncture or sight of blood; and\n* Regular consumption of alcohol defined as either \\> 2 units (glass or shot) of alcoholic beverages per day or \\> 14 units per week.",true,"ALL","18 Years","55 Years",{"count":63,"type":64},24,"ACTUAL","INTERVENTIONAL",[67],"PHASE1","The primary aim of this Phase 1 study is to evaluate the effect of vapendavir daily doses of 528 mg daily (QD) and 264 mg twice daily (BID) on the pharmacokinetic (PK) profile of midazolam, a cytochrome (CYP) 3A4 substrate. Additionally, the effect of midazolam on the PK profile of vapendavir, a PK profile comparison of vapendavir in males and females, as well as the safety of vapendavir will also be assessed.",[70],"Drug-Drug Interaction Healthy Volunteers",[72,73,74],"Aviragen Therapeutics, Inc.","Aviragen Therapeutics","Aviragen","COMPLETED","2018-05-29",{"date":78,"type":64},"2018-05-30",{"date":80,"type":26},"2014-05",{"date":82,"type":64},"2014-06",{"name":84,"class":6},"Biota Scientific Management Pty Ltd",1]