[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100351524":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":51,"centralContacts":38,"locations":55,"responsibleParty":69,"collaborators":38,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":38,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":38,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":38,"overallStatus":91,"whyStopped":38,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Ironwood Pharmaceuticals, Inc.","INDUSTRY",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Healthy Volunteers","EXPERIMENTAL","Microgestin® (EE 30 μg and NET 1500 μg) single dose (Day 1). After a 10-14 day washout, Microgestin® single dose (Day 14) PLUS IW-3718 1500 mg twice daily (Days 13 to 19).",[13,14],"Drug: Microgestin®","Drug: IW-3718",{"label":16,"type":10,"description":17,"interventionNames":18},"Part 2: Healthy Volunteers","Levothyroxine 600 μg single dose (Day 1). After a 35-39 day washout, levothyroxine 600 μg single dose (Day 39) PLUS IW-3718 1500 mg twice daily (Days 38 to 41).",[19,14],"Drug: Levothyroxine",{"label":21,"type":10,"description":22,"interventionNames":23},"Part 3: Healthy Volunteers","Phase 1: Glyburide 5 mg single dose (Day 1). After a 7-10 day washout, glyburide 5 mg single dose (Day 11) PLUS IW-3718 1500 mg twice daily (ie, Days 10 to 14).\n\nPhase 2: Digoxin 0.25 mg single dose (Day 23). After a 10-14 day washout, digoxin 0.25 mg mg single dose (Day 35) PLUS IW-3718 1500 mg twice daily (Days 34 to 42).",[24,25,14],"Drug: Glyburide","Drug: Digoxin",[27,34,39,43,47],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Microgestin®","30 μg\u002F1500 μg tablets for oral administration",[9],[33],"ethinyl estradiol 30 μg and norethindrone 1500 μg",{"type":28,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Levothyroxine","600 μg tablets for oral administration",[16],null,{"type":28,"name":40,"description":41,"armGroupLabels":42,"otherNames":38},"Glyburide","5 mg tablets for oral administration",[21],{"type":28,"name":44,"description":45,"armGroupLabels":46,"otherNames":38},"Digoxin","0.25 mg tablets for oral administration",[21],{"type":28,"name":48,"description":49,"armGroupLabels":50,"otherNames":38},"IW-3718","500-mg film-coated tablets for oral administration",[9,16,21],[52],{"name":53,"affiliation":5,"role":54},"Zurab Machaidze, MD","STUDY_DIRECTOR",[56],{"facility":57,"status":38,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":38},"PPD","Austin","Texas","78744","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-97.74306,30.26715,{"lat":67,"lon":66},{"type":70,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100351524","phase-1-study-to-evaluate-the-effect-of-iw-3718-on-the-pharmacokinetics-of-oral-contraceptive-levothyroxine-glyburide-and-digoxin-in-healthy-adult-volunteers-100351524",false,"NCT03856970","Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers","A Phase 1, Open-Label, Parallel, Sequential, Multi-part Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of an Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers","Inclusion Criteria:\n\n* Is healthy, ambulatory, and 18-50 years of age (inclusive) at screening visit.\n* Weighs at least 50 kg and has a body mass index within 18-35 kg\u002Fm2 at the screening visit.\n* Is not pregnant or breastfeeding at the time of the screening visit and has negative serum pregnancy tests at the screening visit and check-in.\n* Other inclusion criteria per protocol.\n\nExclusion Criteria:\n\n* Has used any prescription drugs, herbal supplements, over-the-counter medication, or dietary supplements (vitamins included) within 4 weeks prior to dosing. If needed, (ie, incidental and limited need), acetaminophen is acceptable.\n* Has consumed grapefruit or grapefruit juice within 4 weeks prior to dosing or plans to consume grapefruit or grapefruit juice before 7 days following the last dose.\n* Has a significant illness that has not resolved within 2 weeks prior to dosing.\n* Has a history of immunodeficiency diseases, including a positive human immunodeficiency virus test result.\n* Has a positive hepatitis B surface antigen or hepatitis C antibody test result.\n* Is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug.\n* Other exclusion criteria per protocol.",true,"ALL","18 Years","50 Years",{"count":83,"type":84},87,"ACTUAL","INTERVENTIONAL",[87],"PHASE1","The primary objectives of this study are the following:\n\n* To evaluate the pharmacokinetics (PK) of a monophasic oral contraceptive's active components, ethinyl estradiol (EE) and norethindrone acetate (NET), following a single oral dose alone and in combination with IW-3718 in healthy adult female participants.\n* To evaluate the PK of levothyroxine following a single oral dose alone and in combination with IW-3718 in healthy adult participants.\n* To evaluate the PK of glyburide following a single oral dose alone and in combination with IW-3718 in healthy adult participants.\n* To evaluate the PK of digoxin following a single oral dose alone and in combination with IW-3718 in healthy adult participants.",[90],"Healthy Volunteers","COMPLETED","2019-07-26",{"date":94,"type":84},"2019-07-29",{"date":96,"type":84},"2019-03-11",{"date":98,"type":84},"2019-07-03",{"name":5,"class":6},1]