[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100384519":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":25,"locations":33,"responsibleParty":46,"collaborators":25,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":25,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":25,"overallStatus":68,"whyStopped":25,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Idorsia Pharmaceuticals Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ACT-1004-1239 Dose level 1 (30 mg) to 5","EXPERIMENTAL","Each dose level will be investigated in a group of 10 male and female subjects (ratio 1:1, male:female), with 8 subjects being administered ACT-1004-239 and 2 subjects matching placebo (ratio 1:1, male:female). Sentinel dosing will be applied at each dose level, i.e., in each group two subjects (ratio 1:1, male:female) will initially receive study treatment (1 on active treatment and 1 on placebo).",[13],"Drug: ACT-1004-1239",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","ACT-1004-1239","ACT-1004-1239 administered as hard capsules for oral use.",[9],null,{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Matching placebo administered as hard capsules for oral use.",[15],[30],{"name":31,"affiliation":5,"role":32},"Clinical Trials","STUDY_DIRECTOR",[34],{"facility":35,"status":25,"city":36,"state":25,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":25},"BlueClinical Phase 1 Hospital de Prelado","Porto","4250-449","Portugal","PT",{"type":41,"coordinates":42},"Point",[43,44],-8.61097,41.1485,{"lat":44,"lon":43},{"type":47,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100384519","phase-1-study-in-healthy-subjects-to-examine-the-safety-and-tolerability-of-act-1004-1239-given-as-multiple-gradually-increasing-doses-and-to-examine-the-effects-of-act-1004-1239-on-the-body-and-the-way-the-body-takes-up-distributes-and-gets-rid-of-act-1004-1239-100384519",false,"NCT04286750","Study in Healthy Subjects to Examine the Safety and Tolerability of ACT-1004-1239 Given as Multiple, Gradually Increasing Doses and to Examine the Effects of ACT-1004-1239 on the Body and the Way the Body Takes up, Distributes, and Gets Rid of ACT-1004-1239","Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-ascending Doses of ACT-1004-1239 in Healthy Subjects","Inclusion Criteria:\n\n* Signed informed consent prior to any study-mandated procedure.\n* Healthy male or female subject aged between 18 and 55 years (inclusive) at Screening.\n* A female subject of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day - 1 and must agree to consistently and correctly use a highly effective method of contraception with a failure rate of ≤1% per year, be sexually inactive, or have a vasectomized partner.\n* A female subject of non-childbearing potential must be postmenopausal, or must have a medical history of previous bilateral salpingectomy, bilateral salpingo-oophorectomy, hysterectomy, premature ovarian failure, XY genotype, Turner syndrome, or uterine agenesis.\n* A male subject must use adequate contraception from first study treatment administration up to at least 90 days after last administration unless he is vasectomized.\n* A male subject must agree to refrain from donation of semen from first study treatment administration up to at least 90 days after last administration.\n\nExclusion Criteria:\n\n* Previous exposure to ACT-1004-1239.\n* Known hypersensitivity to ACT-1004-1239, or any of its excipients.\n* History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment.\n* Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study.\n* Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 3 weeks prior to first study treatment administration.\n* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.\n* Pregnant or lactating woman.\n* Any cardiac condition or illness that may jeopardize the safety of the study subject per investigator judgment based on medical history or 12-lead ECG measured at Screening.\n* Any immunosuppressive treatment within 6 weeks or 5x terminal half-life (t½), whichever is longer, before study treatment administration.",true,"ALL","18 Years","55 Years",{"count":60,"type":61},50,"ACTUAL","INTERVENTIONAL",[64],"PHASE1","Study in healthy subjects to examine the safety and tolerability of ACT-1004-1239 given as multiple, gradually increasing doses and to examine the effects of ACT-1004-1239 on the body and the way the body takes up, distributes, and gets rid of ACT-1004-1239",[67],"Healthy","COMPLETED","2021-01-19",{"date":71,"type":61},"2021-01-20",{"date":73,"type":61},"2020-07-11",{"date":75,"type":61},"2020-09-25",{"name":5,"class":6},1]