[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100304916":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":27,"locations":32,"responsibleParty":45,"collaborators":27,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":27,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":27,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":27,"overallStatus":67,"whyStopped":27,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Janssen-Cilag International NV","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Contraceptive Tablet + JNJ-42847922","EXPERIMENTAL","All participants will receive one oral contraceptive (OC) tablet containing ethinyl estradiol (EE) 0.03 milligram (mg) and levonorgestrel (LN) 0.15 mg once daily on Days 1 to 21 for both cycle 1 and cycle 2. In addition, in cycle 2, participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21. Participants will not be given OC tablet on Days 22 to 28 during cycle 1 and cycle 2 (tablet-free period).",[13,14],"Drug: Ethinyl Estradiol + Levonorgestrel","Drug: JNJ-42847922",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Ethinyl Estradiol + Levonorgestrel","Participants will receive one OC tablet containing EE 0.03 mg and LN 0.15 mg once daily on Days 1 to 21 in cycles 1 and 2.",[9],[22],"Microgynon 30",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"JNJ-42847922","Participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21 in cycle 2.",[9],null,[29],{"name":30,"affiliation":5,"role":31},"Janssen-Cilag International NV Clinical Trial","STUDY_DIRECTOR",[33],{"facility":34,"status":27,"city":35,"state":27,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":27},"SGS Life Science Services","Antwerp","2060","Belgium","BE",{"type":40,"coordinates":41},"Point",[42,43],4.40026,51.22047,{"lat":43,"lon":42},{"type":46,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100304916","phase-1-a-study-to-evaluate-the-effect-of-multiple-oral-doses-of-jnj-42847922-on-the-steady-state-pharmacokinetics-of-an-oral-contraceptive-containing-ethinyl-estradiol-and-levonorgestrel-in-healthy-female-adult-participants-100304916",false,"NCT03249402","A Study to Evaluate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Adult Participants","An Open-label Drug-drug Interaction Study in Healthy Female Adult Subjects to Investigate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel","Inclusion Criteria:\n\n* Be female of childbearing potential (women with tubal ligation are not accepted)\n* Have a body weight equal to or over 45 kilogram (kg) and a body mass index (BMI) 23 within the range of 18 to 30 kilogram \u002F square meter (kg\u002Fm\\^2) inclusive\n* Have a systolic blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive, and diastolic blood pressure no higher than 90 mmHg\n* Agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the last dose of study drug\n* Have a negative serum pregnancy test at screening and a negative predose urine pregnancy test on Day1 and Day 21 of Cycle 1 and Cycle 2\n\nExclusion Criteria:\n\n* Participant has a past history of heart arrhythmias (extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)\n* Participant is currently pregnant or planning to become pregnant or lactating (from screening through at least 8 weeks after receiving the last dose of study drug)\n* Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody positive, or other clinically active liver disease, or tests positive for HBsAg or hepatitis C virus antibody at screening.\n* Participant has a history of or present allergy to the oral contraceptive (OC) or JNJ-42847922, or drugs of these classes, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation\n* Participant has a history of alcohol\u002Fdrug abuse or dependence within 12 months of the study: history of regular alcohol consumption averaging greater than (\\>) 14 drinks\u002Fweek for women within 6 months of screening",true,"FEMALE","18 Years","45 Years",{"count":59,"type":60},24,"ACTUAL","INTERVENTIONAL",[63],"PHASE1","The purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy female adult partcipants.",[66],"Healthy","COMPLETED","2025-04-25",{"date":70,"type":60},"2025-04-27",{"date":72,"type":60},"2017-08-14",{"date":74,"type":60},"2017-11-24",{"name":5,"class":6},1]