[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100299063":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":21,"locations":30,"responsibleParty":44,"collaborators":21,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":21,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":21,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":67,"whyStopped":21,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Takeda","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TAK-954 0.2 mg + Itraconazole 200 mg and TAK-954 0.2mg","EXPERIMENTAL","TAK-954 0.2 milligram (mg), infusion, intravenously, once on Day 1 of First Intervention Period, followed by a minimum of 7-day washout period, further followed by Itraconazole 200 mg, capsule, orally, once daily on Days 1 to 8 along with TAK-954 0.2 mg, infusion, intravenously on Day 4 of Second Intervention Period.",[13,14],"Drug: TAK-954","Drug: Itraconazole",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","TAK-954","TAK-954 Infusion",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Itraconazole","Itraconazole Capsule",[9],[27],{"name":28,"affiliation":5,"role":29},"Medical Director","STUDY_DIRECTOR",[31],{"facility":32,"status":21,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":21},"Pharmaceutical Research Associates, Inc.","Lenexa","Kansas","66219","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-94.73357,38.95362,{"lat":42,"lon":41},{"type":45,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100299063","phase-1-a-study-to-evaluate-the-effect-of-the-potent-cytochrome-p-450-3a4-cyp3a4-inhibitor-itraconazole-on-the-pharmacokinetics-pk-of-tak-954-in-healthy-adult-participants-100299063",true,"NCT03173170","A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants","A Single-Sequence, Open-Label, 2-Period Crossover Trial to Evaluate the Effect of the Potent Cytochrome P-450 3A4 Inhibitor Itraconazole on the Pharmacokinetics of TAK-954 in Healthy Adult Subjects","Inclusion Criteria:\n\n1. Is a man or woman (with no child bearing potential) aged 18 to 55 years, inclusive, at the Screening Visit.\n2. Has a body mass index (BMI) from greater than or equal to (\\>=) 18 and less than or equal to (\\\u003C=) 30 kilogram per square meter (kg\u002Fm\\^2) and has a body weight greater than (\\>) 50 kilogram (kg) at the Screening Visit.\n3. Is a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the initial dose of trial drug\u002Finvasive procedure.\n\nExclusion Criteria:\n\n1. Has a positive alcohol or drug screen.\n2. Had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter (mL)) within 8 weeks of the first dose of study drug.\n3. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer \\[354 mL\u002F12 ounces\\], wine \\[118 mL\u002F4 ounces\\], or distilled spirits \\[29.5 mL\u002F1 ounce\\] per day).\n4. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.\n5. Has a substance abuse disorder.","ALL","18 Years","55 Years",{"count":57,"type":58},10,"ACTUAL","INTERVENTIONAL",[61],"PHASE1","The purpose of this study is to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on the single-dose PK of TAK-954.",[64],"Healthy Participants",[66],"Drug Therapy","COMPLETED","2018-07-20",{"date":70,"type":58},"2019-01-15",{"date":72,"type":58},"2017-05-31",{"date":74,"type":58},"2017-07-24",{"name":5,"class":6},1]