[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524234":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":43,"centralContacts":42,"locations":47,"responsibleParty":61,"collaborators":42,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":42,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":42,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":42,"overallStatus":83,"whyStopped":42,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8,15,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1a","EXPERIMENTAL","3 single ascending doses of SAR442168 or placebo in fasted and fed (high-fat breakfast) conditions",[13,14],"Drug: Tolebrutinib","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Part 1b","2 single doses of SAR442168 under fed conditions (moderate-fat breakfast).",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Part 1c","1 single dose of SAR442168 under fasting and fed conditions (high-fat breakfast).",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Part 1d","1 single dose of SAR442168 under fasting and fed conditions (Standardized high-fat breakfast).",[13],{"label":28,"type":10,"description":29,"interventionNames":30},"Part 2","3 ascending once-daily repeated single doses of SAR442168 or placebo for 14 days under fed conditions (moderate-fat breakfast)",[13,14],[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Tolebrutinib","Tablet, oral",[9,16,20,24,28],[38],"SAR442168",{"type":33,"name":40,"description":35,"armGroupLabels":41,"otherNames":42},"Placebo",[9,28],null,[44],{"name":45,"affiliation":5,"role":46},"Clinical Sciences & Operations","STUDY_DIRECTOR",[48],{"facility":49,"status":42,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":42},"New Orleans Clinical Research Site Number : 8400001","Knoxville","Tennessee","37920","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-83.92074,35.96064,{"lat":59,"lon":58},{"type":62,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100524234","phase-1-study-of-the-tolerability-and-pharmacokinetics-of-oral-doses-of-sar442168-with-a-food-effect-investigation-in-healthy-adult-participants-100524234",false,"NCT06106074","Study of the Tolerability and Pharmacokinetics of Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants","A Randomized, Double-blind, Placebo-controlled Study of the Tolerability and Pharmacokinetics of Ascending Single and 14-day Repeated Oral Doses of SAR442168 With a Food Effect Investigation in Healthy Adult Participants","Inclusion Criteria:\n\n* Having given written informed consent prior to undertaking any study-related procedure.\n\nExclusion Criteria:\n\n* Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",true,"ALL","18 Years","45 Years",{"count":75,"type":76},71,"ACTUAL","INTERVENTIONAL",[79],"PHASE1","This is a randomized, placebo-controlled, four-part, Phase I, first in human (FIH) study to assess the tolerability and pharmacokinetics (PK) of ascending single and 14-day repeated oral doses of SAR442168 with a food effect investigation in healthy adult participants.\n\n* In Part 1a: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s)after ascending single oral doses in fasted and fed conditions\n* In Part 1b: The relationship of PK of SAR442168 and metabolite(s) in cerebrospinal fluid (CSF) to that in plasma after single oral doses given in fed conditions (moderate-fat meal)\n* In Part 1c: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (high-fat)\n* In Part 1d: The effect of a high-fat meal on the pharmacokinetics of SAR442168 and metabolite(s) (standardized high-fat meal)\n* In Part 2: The tolerability and safety of SAR442168 and the pharmacokinetic parameters of SAR442168 and metabolite(s) after 14-day ascending repeated oral doses of SAR442168 given in fed conditions (moderate-fat meal).",[82],"Multiple Sclerosis","COMPLETED","2023-10-24",{"date":86,"type":76},"2023-10-30",{"date":88,"type":76},"2020-08-10",{"date":90,"type":76},"2022-05-23",{"name":5,"class":6},1]