[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653811":3},{"organization":4,"outcomesModule":7,"designInfo":60,"detailedDescription":66,"studyPopulation":11,"armGroups":67,"interventions":90,"overallOfficials":11,"centralContacts":109,"locations":115,"responsibleParty":128,"collaborators":11,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":11,"eligibilityCriteria":136,"healthyVolunteers":137,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":11,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":11,"overallStatus":118,"whyStopped":11,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":29,"otherOutcomes":11},[9,13,16,19,21,23,25,27],{"measure":10,"description":11,"timeFrame":12},"Part A: Maximum Observed Plasma Concentration (Cmax) of LNG\u002FEE in the Absence and Presence of VX-407",null,"From Day 1 up to Day 7 and Day 21 up to Day 27",{"measure":14,"description":11,"timeFrame":15},"Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of norelgestromin (NGMN) and norgestrel (NG) (active metabolites of NGM) and EE in the Absence and Presence of VX-407","From Day 1 up to Day 9 and Day 23 up to Day 31",{"measure":17,"description":11,"timeFrame":18},"Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of NET and EE in the Absence and Presence of VX-407","From Day 1 up to Day 5 and Day 19 up to Day 23",{"measure":20,"description":11,"timeFrame":12},"Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of VX-407",{"measure":22,"description":11,"timeFrame":12},"Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG\u002FEE in the Absence and Presence of VX-407",{"measure":24,"description":11,"timeFrame":15},"Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of norelgestromin (NGMN) and norgestrel (NG) (active metabolites of NGM) and EE in the Absence and Presence of VX-407",{"measure":26,"description":11,"timeFrame":18},"Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of NET and EE in the Absence and Presence of VX-407",{"measure":28,"description":11,"timeFrame":12},"Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of DRSP and EE in the Absence and Presence of VX-407",[30,33,36,39,41,44,47,50,52,54,56,58],{"measure":31,"description":11,"timeFrame":32},"Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","From Day 1 up to Day 36",{"measure":34,"description":11,"timeFrame":35},"Part B (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","From Day 1 Up to Day 39",{"measure":37,"description":11,"timeFrame":38},"Part C (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","From Day 1 up to Day 32",{"measure":40,"description":11,"timeFrame":32},"Part D (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)",{"measure":42,"description":11,"timeFrame":43},"Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407","Days 9, 15 and 21 up to Day 27",{"measure":45,"description":11,"timeFrame":46},"Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407","Days 11, 17 and 23 up to Day 31",{"measure":48,"description":11,"timeFrame":49},"Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407","Days 7, 13 and 19 up to Day 23",{"measure":51,"description":11,"timeFrame":43},"Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407",{"measure":53,"description":11,"timeFrame":43},"Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407",{"measure":55,"description":11,"timeFrame":46},"Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407",{"measure":57,"description":11,"timeFrame":49},"Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407",{"measure":59,"description":11,"timeFrame":43},"Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407",{"allocation":61,"interventionModel":62,"interventionModelDescription":11,"primaryPurpose":63,"observationalModel":11,"timePerspective":11,"maskingInfo":64},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":65,"maskingDescription":11,"whoMasked":11},"NONE","The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).",[68,75,80,85],{"label":69,"type":70,"description":71,"interventionNames":72},"Part A: VX-407 With Levonorgestrel\u002FEthinyl Estradiol (LNG\u002FEE)","EXPERIMENTAL","Participants will receive a single dose of LNG\u002FEE on Days 1 and 21 in fasted state. Participants will also receive VX-407 every 12 hours (q12h) from Days 8 through 26 in fasted state.",[73,74],"Drug: VX-407","Drug: LNG\u002FEE",{"label":76,"type":70,"description":77,"interventionNames":78},"Part B (Optional): VX-407 With Norgestimate\u002FEthinyl Estradiol (NGM\u002FEE)","Participants will receive a single dose of NGM\u002FEE on Days 1 and 23 in fasted state. Participants will also receive VX-407 q12h from Days 10 through 30 in fasted state.",[73,79],"Drug: NGM\u002FEE",{"label":81,"type":70,"description":82,"interventionNames":83},"Part C (Optional): VX-407 With Norethindrone\u002FEthinyl Estradiol (NET\u002FEE)","Participants will receive a single dose of NET\u002FEE on Days 1 and 19 in fasted state. Participants will also receive VX-407 q12h from Days 6 through 22 in fasted state.",[73,84],"Drug: NET\u002FEE",{"label":86,"type":70,"description":87,"interventionNames":88},"Part D (Optional): VX-407 With Drospirenone\u002FEthinyl Estradiol (DRSP\u002FEE)","Participants will receive a single dose of DRSP\u002FEE on Days 1 and 21 in fasted state. Participants will also receive VX-407 q12h from Days 8 through 26 in fasted state.",[73,89],"Drug: DRSP\u002FEE",[91,96,100,103,106],{"type":92,"name":93,"description":94,"armGroupLabels":95,"otherNames":11},"DRUG","VX-407","Tablets for Oral Administration.",[69,76,81,86],{"type":92,"name":97,"description":98,"armGroupLabels":99,"otherNames":11},"LNG\u002FEE","Combination Tablets for Oral Administration.",[69],{"type":92,"name":101,"description":98,"armGroupLabels":102,"otherNames":11},"NGM\u002FEE",[76],{"type":92,"name":104,"description":98,"armGroupLabels":105,"otherNames":11},"NET\u002FEE",[81],{"type":92,"name":107,"description":98,"armGroupLabels":108,"otherNames":11},"DRSP\u002FEE",[86],[110],{"name":111,"role":112,"phone":113,"phoneExt":11,"email":114},"Medical Information","CONTACT","617-341-6777","medicalinfo@vrtx.com",[116],{"facility":117,"status":118,"city":119,"state":11,"zip":11,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":11},"Altasciences - Beaumont Clinic Montreal","RECRUITING","Montreal","Canada","CA",{"type":123,"coordinates":124},"Point",[125,126],-73.58781,45.50884,{"lat":126,"lon":125},{"type":129,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100653811","phase-1-effects-of-vx-407-on-the-pharmacokinetics-of-combined-oral-contraceptives-100653811",false,"NCT07792408","Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives","A Phase 1, Open-label Drug Interaction Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives","Key Inclusion Criteria:\n\n* Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg\u002Fm\\^2), inclusive\n* A total body weight of greater than (\\>) 50 kg\n\nKey Exclusion Criteria:\n\n* History of febrile illness within 5 days before the first dose of study drug\n* Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug\n\nOther protocol defined Inclusion\u002FExclusion criteria will apply.",true,"FEMALE","18 Years","50 Years",{"count":142,"type":143},148,"ESTIMATED","INTERVENTIONAL",[146],"PHASE1","The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.",[149],"Autosomal Dominant Polycystic Kidney Disease (ADPKD)","2026-09-25",{"date":152,"type":153},"2026-09-30","ACTUAL",{"date":155,"type":153},"2026-09-01",{"date":157,"type":143},"2027-03-20",{"name":5,"class":6},1]