[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500549":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":31,"locations":39,"responsibleParty":53,"collaborators":31,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":31,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":31,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":31,"overallStatus":75,"whyStopped":31,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8,14,18,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment A","EXPERIMENTAL","Single dose of SAR443820 tablet in fasted condition",[13],"Drug: SAR443820",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment B","Single dose of SAR443820 capsule in fasted condition",[13],{"label":19,"type":10,"description":11,"interventionNames":20},"Treatment C",[13],{"label":22,"type":10,"description":23,"interventionNames":24},"Treatment D","Single dose of SAR443820 tablet in fed condition",[13],[26,32],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","SAR443820","Tablet by oral administration",[9,19,22],null,{"type":27,"name":28,"description":33,"armGroupLabels":34,"otherNames":31},"Capsule by oral administration",[15],[36],{"name":37,"affiliation":5,"role":38},"Clinical Sciences & Operations","STUDY_DIRECTOR",[40],{"facility":41,"status":31,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":31},"Prism Research-Site Number:8400001","Saint Paul","Minnesota","55144","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-93.09327,44.94441,{"lat":51,"lon":50},{"type":54,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100500549","phase-1-a-study-in-healthy-adult-male--female-participants-to-assess-the-amount-of-the-study-medicine-sar443820-absorbed-by-the-body-when-given-orally-in-fasted-condition-as-a-tablet-versus-as-a-capsule-part-1-and-when-given-orally-as-a-tablet-in-fasted-condition-versus-as-a-tablet-after-food-part-2-100500549",false,"NCT05797701","A Study in Healthy Adult Male & Female Participants to Assess the Amount of the Study Medicine (SAR443820) Absorbed by the Body, When Given Orally in Fasted Condition as a Tablet Versus as a Capsule (Part 1) and When Given Orally as a Tablet in Fasted Condition Versus as a Tablet After Food (Part 2)","An Open-label, Randomized, 2-sequence, 2-period, 2-treatment, 2-part Study to Evaluate the Relative Bioavailability of SAR443820 in Tablet Formulation Versus Capsule Formulation in Fasted Condition (Part 1) and the Food-effect on SAR443820 in Tablet Formulation (Part 2) in Healthy Adult Male and Female Participants","Inclusion Criteria:\n\n* Male or female participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring\n* Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index between 18.0 and 30.0 kg\u002Fm\\^2, inclusive\n* All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* Having given written informed consent prior to undertaking any study-related procedure\n\nExclusion Criteria:\n\n* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness\n* Any medication (including St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, with the exception of hormonal contraception or menopausal hormone replacement therapy; any non-live Covid-19 vaccine within the last 2 weeks before randomization, any live attenuated vaccine within the last 28 days before randomization and any other non-vaccine biological drugs given within 4 months before randomization\n* Positive result for hepatitis B, C or human immunodeficiency virus (HIV)\n* Positive result on urine drug screen\n* Positive urine alcohol test\n* Positive severe acute respiratory syndrom coronavirus 2 (SARS-CoV-2) test\n* Any consumption of citrus fruits (grapefruit, orange, etc) or their juices within 5 days before inclusion\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.",true,"ALL","18 Years","55 Years",{"count":67,"type":68},18,"ACTUAL","INTERVENTIONAL",[71],"PHASE1","Part 1:\n\nThis is an open label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment A and Treatment B for Part 1), study part to determine the relative bioavailability of SAR443820 in tablet formulation versus capsule formulation under fasted conditions.\n\nTwo treatments are as follows:\n\n* Treatment A: SAR443820 - tablet formulation in fasted condition\n* Treatment B: SAR443820 - capsule formulation in fasted condition Each administration will be a single dose of SAR443820 separated by a wash out of at least 5 days.\n\nPart 2:\n\nThis is an open-label, balanced randomized, single dose, 2-sequence, 2-period (period 1 and period 2), 2-treatment crossover (between Treatment C and Treatment D for Part 2) study part to perform a preliminary assessment of the effect of a high-fat meal on pharmacokinetic parameters of single dose of SAR443820 in tablet formulation.\n\nTwo treatments are as follows:\n\n* Treatment C: SAR443820 - tablet formulation in fasted condition\n* Treatment D: SAR443820 - tablet formulation in fed condition Each administration will be a single dose of SAR443820 separated by a wash out of at least 5 days.\n\nParticipants are not allowed to participate in more than one part of the study. In both Parts 1 and 2, the assessment of pharmacokinetic, safety and tolerability are performed at each treatment period at baseline (prior single dosing) up to 48-hour postdosing in healthy adult male and female participants.",[74],"Amyotrophic Lateral Sclerosis (Healthy Volunteers)","COMPLETED","2023-03-22",{"date":78,"type":68},"2023-04-04",{"date":80,"type":68},"2021-07-28",{"date":82,"type":68},"2021-09-06",{"name":5,"class":6},1]