[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628248":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":36,"studyPopulation":36,"armGroups":48,"interventions":63,"overallOfficials":81,"centralContacts":85,"locations":94,"responsibleParty":114,"collaborators":116,"id":120,"slug":36,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":36,"eligibilityCriteria":125,"healthyVolunteers":126,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":36,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":36,"overallStatus":97,"whyStopped":36,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Clear Scientific, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":29,"otherOutcomes":36},[9,13,16,19,22,26],{"measure":10,"description":11,"timeFrame":12},"Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations","Physical examinations","3 days plus follow-up on Day 10",{"measure":14,"description":15,"timeFrame":12},"Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)","Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted",{"measure":17,"description":18,"timeFrame":12},"Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs","Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature",{"measure":20,"description":21,"timeFrame":12},"Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters","Clinical chemistry, hematology, coagulation, and urinalysis",{"measure":23,"description":24,"timeFrame":25},"Time course of CS-1103 blood and urine concentrations","Measurement of plasma and urine concentrations of CS-1103","48 hours",{"measure":27,"description":28,"timeFrame":25},"Time course and magnitude of urine excretion of fentanyl","Measurement of concentration of fentanyl in urine",[30,33],{"measure":31,"description":32,"timeFrame":25},"Effect of CS-1103 and fentanyl on QT interval","Concentration-QT correlation performed on baseline-corrected QTcF time-matched with PK for fentanyl and CS-1103 in plasma",{"measure":34,"description":35,"timeFrame":25},"Effect of CS-1103 on the naloxone plasma and urine PK, if any","Measurement of standard urine and plasma PK parameters between placebo and CS-1103 treated participants",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":43},"QUADRUPLE",[44,45,46,47],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[49,57],{"label":50,"type":51,"description":52,"interventionNames":53},"Placebo","PLACEBO_COMPARATOR","Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by placebo (saline).",[54,55,56],"Drug: Naloxone Hydrochloride","Drug: Fentanyl","Drug: Sterile Saline",{"label":58,"type":59,"description":60,"interventionNames":61},"Active","ACTIVE_COMPARATOR","Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by CS-1103 (1,000 mg, IV).",[54,55,62],"Drug: CS-1103",[64,69,73,77],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":36},"DRUG","Naloxone Hydrochloride","Naloxone for intravenous administration",[58,50],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":36},"Fentanyl","Fentanyl for intravenous administration",[58,50],{"type":65,"name":74,"description":75,"armGroupLabels":76,"otherNames":36},"Sterile Saline","Sterile Saline for intravenous administration",[50],{"type":65,"name":78,"description":79,"armGroupLabels":80,"otherNames":36},"CS-1103","CS-1103 for intravenous administration",[58],[82],{"name":83,"affiliation":5,"role":84},"Xinhua Li, Ph.D.","PRINCIPAL_INVESTIGATOR",[86,91],{"name":87,"role":88,"phone":89,"phoneExt":36,"email":90},"Anna Del Rosario, B.S.","CONTACT","617-621-8500","adelrosario@clearsci.com",{"name":92,"role":88,"phone":89,"phoneExt":36,"email":93},"Piercen Oliver, Ph.D.","poliver@clearsci.com",[95],{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"California Clinical Trials Medical Group","RECRUITING","Glendale","California","91206","United States","US",{"type":104,"coordinates":105},"Point",[106,107],-118.25508,34.14251,{"lat":107,"lon":106},[110],{"name":111,"role":88,"phone":112,"phoneExt":36,"email":113},"Lev Gertsik, M.D.","888-228-7425","study.losangeles@parexel.com",{"type":115,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[117],{"name":118,"class":119},"National Institute on Drug Abuse (NIDA)","NIH","100628248",false,"NCT07459166","A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade","A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Dose of Intravenous CS 1103 Following a Single Intravenous Dose of Fentanyl in Healthy Subjects With Naloxone Blockade","Major Inclusion Criteria:\n\n1. Healthy participants aged 18 to 55 years, inclusive;\n2. Have prior experience with opioids, such as from a dental procedure, chronic pain management, or previous inpatient surgical procedure;\n3. A body mass index between 18.0 to 30.0 kg\u002Fm2, inclusive, and a minimum body weight of 56 kg;\n4. Females must not be lactating and must have a negative pregnancy test during screening and admission.\n\nMajor Exclusion Criteria:\n\n1. Estimated glomerular filtration rate \\\u003C90 mL\u002Fmin\u002F1.73 m2;\n2. History of cardiovascular disease;\n3. History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.",true,"ALL","18 Years","55 Years",{"count":131,"type":132},16,"ESTIMATED","INTERVENTIONAL",[135],"PHASE2","The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of fentanyl (200 μg, IV), with naloxone blockade (400 μg, IV).",[138,139],"Fentanyl Overdose","Fentanyl Poisoning","2026-06-30",{"date":142,"type":143},"2026-07-01","ACTUAL",{"date":145,"type":143},"2026-05-28",{"date":147,"type":132},"2026-10",{"name":5,"class":6},1]