[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100237429":3},{"organization":4,"armGroups":7,"interventions":54,"overallOfficials":94,"centralContacts":60,"locations":99,"responsibleParty":112,"collaborators":60,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":60,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":60,"enrollmentInfo":124,"targetDuration":60,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":143,"whyStopped":60,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Astellas Pharma Inc","INDUSTRY",[8,14,18,23,28,33,37,42,46,50],{"label":9,"type":10,"description":11,"interventionNames":12},"1. Single ascending dose (SAD), ASP1707 dose levels 1-7","EXPERIMENTAL","healthy young male",[13],"Drug: ASP1707 single dose of dose levels 1 -7",{"label":15,"type":10,"description":11,"interventionNames":16},"2. Single ascending dose (SAD), placebo dose levels 1-7",[17],"Drug: Placebo single dose of dose levels 1-7",{"label":19,"type":10,"description":20,"interventionNames":21},"3. Food effect (FE), ASP1707 fasted","Fasted healthy young male",[22],"Drug: ASP1707 single dose fasted",{"label":24,"type":10,"description":25,"interventionNames":26},"4. Food effect (FE), ASP1707 fed","Fed healthy young male",[27],"Drug: ASP1707 single dose fed",{"label":29,"type":10,"description":30,"interventionNames":31},"5. Multiple ascending dose (MAD), ASP1707 dose levels 1-4","healthy elderly male",[32],"Drug: ASP1707 multiple dose of dose levels 1-4",{"label":34,"type":10,"description":30,"interventionNames":35},"6. Multiple ascending dose (MAD), Placebo, dose levels 1-4",[36],"Drug: Placebo multiple dose of dose levels 1-4",{"label":38,"type":10,"description":39,"interventionNames":40},"7. Multiple ascending dose (MAD), ASP1707, dose levels 1-2","healthy pre-menopausal female",[41],"Drug: ASP1707 multiple dose of dose levels 1-2",{"label":43,"type":10,"description":39,"interventionNames":44},"8. Multiple ascending dose (MAD), Placebo dose levels 1-2",[45],"Drug: Placebo multiple dose of dose levels 1-2",{"label":47,"type":10,"description":39,"interventionNames":48},"9. Parallel multiple dose, ASP1707 dose levels 1-3",[49],"Drug: ASP1707 parallel multiple dose of dose levels 1-3",{"label":51,"type":10,"description":39,"interventionNames":52},"10. Parallel multiple dose, Placebo",[53],"Drug: Placebo parallel multiple dose",[55,61,65,69,72,76,79,83,86,90],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"DRUG","ASP1707 single dose of dose levels 1 -7","Oral, dose escalation",[9],null,{"type":56,"name":62,"description":63,"armGroupLabels":64,"otherNames":60},"Placebo single dose of dose levels 1-7","Oral, dose escalation, healthy young male",[15],{"type":56,"name":66,"description":67,"armGroupLabels":68,"otherNames":60},"ASP1707 single dose fasted","Oral, healthy young male",[19],{"type":56,"name":70,"description":67,"armGroupLabels":71,"otherNames":60},"ASP1707 single dose fed",[24],{"type":56,"name":73,"description":74,"armGroupLabels":75,"otherNames":60},"ASP1707 multiple dose of dose levels 1-4","Oral, multiple dose escalation, healthy elderly male",[29],{"type":56,"name":77,"description":74,"armGroupLabels":78,"otherNames":60},"Placebo multiple dose of dose levels 1-4",[34],{"type":56,"name":80,"description":81,"armGroupLabels":82,"otherNames":60},"ASP1707 multiple dose of dose levels 1-2","Oral, multiple dose escalation, healthy pre-menopausal female",[38],{"type":56,"name":84,"description":81,"armGroupLabels":85,"otherNames":60},"Placebo multiple dose of dose levels 1-2",[43],{"type":56,"name":87,"description":88,"armGroupLabels":89,"otherNames":60},"ASP1707 parallel multiple dose of dose levels 1-3","Oral, multiple dose, healthy pre-menopausal female",[47],{"type":56,"name":91,"description":92,"armGroupLabels":93,"otherNames":60},"Placebo parallel multiple dose","Oral, dose escalation, healthy pre-menopausal female",[51],[95],{"name":96,"affiliation":97,"role":98},"Clinical Study Manager","Astellas Pharma Europe B.V.","STUDY_CHAIR",[100],{"facility":101,"status":60,"city":102,"state":60,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":111,"contacts":60},"SGS Life Science Services, Aster","Paris","75015","France","FR",{"type":107,"coordinates":108},"Point",[109,110],2.3488,48.85341,{"lat":110,"lon":109},{"type":113,"investigatorFullName":60,"investigatorTitle":60,"investigatorAffiliation":60,"oldNameTitle":60,"oldOrganization":60},"SPONSOR","100237429","phase-1-a-study-to-assess-the-safety-tolerability-and-effects-of-single-and-multiple-ascending-doses-of-asp1707-in-healthy-male-and-pre-menopausal-female-subjects-including-a-comparison-of-the-effects-under-fasted-and-fed-conditions-in-healthy-young-male-subjects-100237429",false,"NCT02368912","A Study to Assess the Safety, Tolerability and Effects of Single and Multiple Ascending Doses of ASP1707 in Healthy Male and Pre-menopausal Female Subjects, Including a Comparison of the Effects Under Fasted and Fed Conditions in Healthy Young Male Subjects","A Double Blind, Randomized, Placebo-controlled, Ascending Single and Multiple Oral Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1707 in Healthy Young and Elderly Male Subjects and in Healthy Pre-menopausal Female Subjects Including an Open-label Comparison of Pharmacokinetics Under Fasted and Fed Conditions in Healthy Young Male Subjects","Inclusion Criteria:\n\nParts 1 \\& 2:\n\n* Healthy young male subject aged 18 to 45 years inclusive\n* Body Mass Index more than or equal to 18.5 and less than 30.0 kg\u002Fm2.\n* Male subjects must be non-fertile, or must practice an adequate contraceptive method to prevent pregnancies.\n\nPart 3:\n\n* Healthy elderly male subject aged 55 years or older, or healthy pre-menopausal female subject aged 18 to 45 inclusive.\n* Body Mass Index more than or equal to 18.5 and less than 30.0 kg\u002Fm2.\n* Male subject must be non-fertile, or must practice adequate contraceptive methods.\n* Female subjects must be of non-child bearing potential, i.e. surgically sterilized or practice adequate (double barrier) non-hormonal contraceptive methods.\n\nPart 4:\n\n* Healthy pre-menopausal female subject aged 18 to 45 inclusive.\n* Body Mass Index more than or equal to 18.5 and less than 30.0 kg\u002Fm2.\n* Female subjects must be of non-child bearing potential, i.e. surgically sterilized or practice adequate contraceptive methods.\n* Females having a regular menstruation cycle with a duration between 25 up to 30 days.\n\nExclusion Criteria:\n\nParts 1 \\& 2:\n\n* Male subjects with out-of-range Testosterone levels in serum at screening.\n* Subjects with any history of cancer.\n* Any of the liver function tests (i.e. ALT and AST) above the upper limit of normal.\n* A QTc interval of \\> 430 ms after repeated measurements.\n* Regular use of any inducer of metabolism (e.g. barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.\n* Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.\n\nPart 3:\n\n* Pregnancy within 6 months before screening assessment or breast feeding 3 months before screening.\n* Male subjects with out-of-range T levels in serum at screening.\n* Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.\n\nPart 4:\n\n* Pregnancy within 6 months before screening assessment or breast feeding 3 months before screening.\n* Use of any hormonal interfering contraceptives in the 3 months before admission (for 3 consecutive menstruation cycles) OR any evidence of unovulatory menstrual cycles.\n* Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.",true,"ALL","18 Years",{"count":125,"type":126},176,"ACTUAL","INTERVENTIONAL",[129],"PHASE1","This study consists of four parts:\n\nPart 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in healthy young male subjects to evaluate the safety, tolerability pharmacokinetics (PK) and effect on certain hormones and if possible to determine the highest well-tolerated dose of ASP1707 in healthy young male subjects under fasted conditions.\n\nPart 2 is an open label, randomized crossover, single dose study to determine the effect of food on the pharmacokinetics of ASP1707and effect on certain hormones in healthy young male subjects.\n\nPart 3 is a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability and pharmacokinetics (PK) of ASP1707 in healthy elderly men and healthy premenopausal females, and to determine the effect on certain hormones in males. Age and gender is also evaluated.\n\nPart 4 is a randomized, double-blind, placebo-controlled, parallel, multiple dose study to evaluate the safety, tolerability and PK of ASP1707, and its effect on certain hormones in healthy pre-menopausal female subjects.",[132,133],"Pharmacokinetics of ASP1707","Pharmacodynamics of ASP1707",[135,136,137,138,139,140,141,142],"Phase 1","ASP1707","Dose escalation","Food effect","Maximum tolerated dose (MTD)","Healthy subjects","Single ascending dose","Multiple ascending dose","COMPLETED","2015-02-17",{"date":146,"type":147},"2015-02-23","ESTIMATED",{"date":149,"type":60},"2010-06",{"date":151,"type":126},"2011-08",{"name":97,"class":6},1]