[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100276988":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":38,"centralContacts":29,"locations":42,"responsibleParty":54,"collaborators":29,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":29,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":29,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":29,"overallStatus":76,"whyStopped":29,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OC + AL-335 + ODV + 3-DAA combination","EXPERIMENTAL","Participants will receive single dose of 3 milligram (mg) drospirenone\u002F0.02 mg ethinylestradiol \\[OC\\] on Day 1, AL-335 800 mg once daily on Days 5 and 6, a single dose of AL-335 800 mg + a single dose of OC on Day 7, ODV 25 mg once daily on Days 12 to 24, followed by a single dose of ODV 25 mg and a single dose of OC on Day 25, followed by ODV 25 mg + AL-335 800 mg + simeprevir (SMV) 75 mg \\[3-DAA combination\\] once daily on Days 26 to 31, followed by a single dose of 3-DAA combination and a single dose of OC on Day 32.",[13,14,15,16],"Drug: Drospirenone\u002Fethinylestradiol","Drug: AL-335","Drug: Odalasvir (ODV)","Drug: Simeprevir (SMV)",[18,25,30,34],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Drospirenone\u002Fethinylestradiol","Each tablet contains 3 mg drospirenone and 0.02 mg ethinylestradiol to be taken orally on Days 1, 6, 25, and 32.",[9],[24],"Yaz®",{"type":19,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"AL-335","AL-335 (800 mg) tablet once daily on Days 5-7 and then on Days 26-32 (as a component of 3-DAA combination) to be taken orally.",[9],null,{"type":19,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Odalasvir (ODV)","ODV 25 mg tablet once daily on Days 12-25 and then on Days 26-32 (as a component of 3-DAA combination) to be taken orally.",[9],{"type":19,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Simeprevir (SMV)","SMV 75 mg capsule as a component of 3-DAA combination to be taken orally on Days 26-32.",[9],[39],{"name":40,"affiliation":5,"role":41},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[43],{"facility":29,"status":29,"city":44,"state":45,"zip":29,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":29},"Overland Park","Kansas","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-94.67079,38.98223,{"lat":52,"lon":51},{"type":55,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100276988","phase-1-to-evaluate-the-effects-of-odalasvir-and-al-335-with-simeprevir-on-the-single-dose-pharmacokinetics-of-ethinylestradiol-and-drospirenone-in-healthy-female-participants-100276988",false,"NCT02885454","To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants","A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Effects of Odalasvir and AL-335 at Steady-state, Given as Single Agents and in Combination With Simeprevir, on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone","Inclusion Criteria:\n\n* Participant must be a female of childbearing potential with a normal menstrual cycle\n* Participant must have a body mass index (BMI; weight in kg divided by the square of height in meters) between 18.0 and 30.0 kilogram per square meter (kg\u002Fm\\^2), extremes included, and a body weight not less than 50.0 kilogram (kg)\n* Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted\n* Participant must have a negative serum (beta human chorionic gonadotropin \\[beta- hCG\\]) pregnancy test at screening\n* Participant must have a negative highly sensitive urine pregnancy test at Day -1\n\nExclusion Criteria:\n\n* Participant is peri- or postmenopausal, or participant with bilateral oophorectomia\n* Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening\n* Participant has previously been dosed with simeprevir (SMV), odalasvir (ODV), or AL-335 in more than 3 single dose studies, or a multiple-dose study with SMV, ODV, or AL-335\n* Participant with currently active gynecological disorders including, but not limited to, vaginal bleeding without an obvious reason and hyperprolactinemia with or without galactorrhea\n* Participant with a past history of: heart arrhythmias (example, extrasystolic rhythms or tachycardia at rest). Isolated extrasystolic beats are not exclusionary; risk factors associated with Torsade de Pointes such as hypokalemia; family history of short\u002Flong QT syndrome; sudden unexplained death (including sudden infant death syndrome \\[SIDS\\]) in a first-degree relative (that is, sibling, offspring, or biological parent)",true,"FEMALE","18 Years","45 Years",{"count":68,"type":69},24,"ACTUAL","INTERVENTIONAL",[72],"PHASE1","The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA) ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone and ethinylestradiol in healthy female participants.",[75],"Healthy","COMPLETED","2017-01-20",{"date":79,"type":80},"2017-01-23","ESTIMATED",{"date":82,"type":29},"2016-08",{"date":84,"type":69},"2016-12",{"name":5,"class":6},1]