[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100426190":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":38,"centralContacts":33,"locations":42,"responsibleParty":56,"collaborators":33,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":33,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":33,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":33,"overallStatus":78,"whyStopped":33,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},{"fullName":5,"class":6},"Ipsen","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"PK Cohort 1","EXPERIMENTAL","Subjects received three single oral doses of palovarotene on Days 1, 6, and 11, separated by 5-day washout periods.\n\nSequence A-B-C: Subjects received a single oral dose of palovarotene whole capsule under fasting conditions (at least a 10-hour overnight fast); followed by a single oral dose of palovarotene whole capsule 30 minutes after the start of a standardized high-fat, high-caloric breakfast; and then followed by a single oral dose of palovarotene sprinkled on 1 teaspoon of apple sauce, administered 30 minutes after the start of a standardized high-fat, high-caloric breakfast.",[13],"Drug: Palovarotene",{"label":15,"type":10,"description":16,"interventionNames":17},"PK Cohort 2","Subjects received three single oral doses of palovarotene on Days 1, 6, and 11, separated by 5-day washout periods.\n\nSequence B-C-A: Subjects received a single oral dose of palovarotene whole capsule 30 minutes after the start of a standardized high-fat, high-caloric breakfast; followed by a single oral dose of palovarotene sprinkled on 1 teaspoon of apple sauce, administered 30 minutes after the start of a standardized high-fat, high-caloric breakfast; and then followed by a single oral dose of palovarotene whole capsule under fasting conditions (at least a 10-hour overnight fast).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"PK Cohort 3","Subjects received three single oral doses of palovarotene on Days 1, 6, and 11, separated by 5-day washout periods.\n\nSequence C-A-B: Subjects received a single oral dose of palovarotene sprinkled on 1 teaspoon of apple sauce, administered 30 minutes after the start of a standardized high-fat, high-caloric breakfast; followed by a single oral dose of palovarotene whole capsule under fasting conditions (at least a 10-hour overnight fast); and then followed by a single oral dose of palovarotene whole capsule 30 minutes after the start of a standardized high-fat, high-caloric breakfast.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Drug-Drug interaction (DDI) Cohort","On the morning of Day 1, subjects received a single dose of midazolam 30 minutes after the start of a standardized breakfast. On Day 2 (after the 24-hour midazolam blood draw) through Day 15, subjects received a daily, single dose of palovarotene in the morning 30 minutes after the start of a standardized breakfast. A second dose of midazolam was administered on Day 15 in the morning (immediately following the palovarotene dose) 30 minutes after the start of a standardized breakfast.",[13,26],"Drug: midazolam",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Palovarotene","oral capsules",[23,9,15,19],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"midazolam","oral syrup",[23],[39],{"name":40,"affiliation":5,"role":41},"Ipsen Medical Director","STUDY_DIRECTOR",[43],{"facility":44,"status":33,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":33},"Cambridge Ipsen US","Cambridge","Massachusetts","02142","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-71.10561,42.3751,{"lat":54,"lon":53},{"type":57,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100426190","phase-1-study-evaluating-the-effect-of-food-on-the-pharmacokinetics-of-palovarotene-and-the-effect-of-palovarotene-on-the-pharmacokinetics-of-the-cyp3a4-substrate-midazolam-in-two-cohorts-of-healthy-adult-subjects-100426190",false,"NCT04829773","Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects","An Open-Label Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects","Key Inclusion Criteria:\n\n* Generally healthy male or female aged 18 to 55 years, inclusive; body mass index (BMI) of 18 to 30 kg\u002Fm2 and a body weight of \\>50 kg; resting pulse of \\>45 bpm and \\\u003C100 bpm; systolic and diastolic blood pressure of \\\u003C140\u002F90 mmHg\n\nKey Exclusion Criteria:\n\n* a history or current evidence of a clinically significant or uncontrolled disease, disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs\n* exposure to synthetic oral retinoids or creams containing retinoids in the past 30 days prior to the signature of the informed consent.\n* history or presence of silent infections, including positive tests for human immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2), hepatitis B virus (HBV), or hepatitis C virus (HCV)\n* history of allergy or hypersensitivity to retinoids, gelatin, or lactose\n* For the DDI component only, the subject had a history of allergy or hypersensitivity to benzodiazepines, midazolam, cherries, or midazolam formulation excipients",true,"ALL","18 Years","55 Years",{"count":70,"type":71},48,"ACTUAL","INTERVENTIONAL",[74],"PHASE1","Study to evaluate the effect of food and the effect of swallowing capsule whole versus sprinkling on apple sauce on the pharmacokinetics (PK)\u002Fbioavailability of palovarotene, and evaluate the effect of palovarotene on the PK of the CYP3A4 substrate midazolam.",[77],"Fibrodysplasia Ossificans Progressiva","COMPLETED","2021-04-01",{"date":81,"type":71},"2021-04-02",{"date":83,"type":71},"2019-01-03",{"date":85,"type":71},"2019-03-29",{"name":87,"class":6},"Clementia Pharmaceuticals Inc.",1]