[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630443":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":11,"studyPopulation":11,"armGroups":35,"interventions":46,"overallOfficials":54,"centralContacts":11,"locations":58,"responsibleParty":80,"collaborators":11,"id":82,"slug":11,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":11,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":11,"overallStatus":61,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Trevi Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Relative Bioavailability of NAL ER",null,"Predose and at multiple timepoints postdose (from Day 1 to Day 8)",[14,16,18,20,22,24,26],{"measure":15,"description":11,"timeFrame":12},"Maximum Plasma Concentration (Cmax) of NAL ER",{"measure":17,"description":11,"timeFrame":12},"Time to Reach Maximum Observed Concentration (Tmax) of NAL ER",{"measure":19,"description":11,"timeFrame":12},"Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER",{"measure":21,"description":11,"timeFrame":12},"Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER",{"measure":23,"description":11,"timeFrame":12},"Apparent Terminal Rate Constant (λz) of NAL ER",{"measure":25,"description":11,"timeFrame":12},"Apparent Terminal Half-Life (t1\u002F2) of NAL ER",{"measure":27,"description":11,"timeFrame":28},"Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)","Up to Day 18",{"allocation":30,"interventionModel":31,"interventionModelDescription":11,"primaryPurpose":32,"observationalModel":11,"timePerspective":11,"maskingInfo":33},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":34,"maskingDescription":11,"whoMasked":11},"NONE",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"Cohort 1: NAL ER Dose A","EXPERIMENTAL","Participants will receive NAL ER Dose A on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences.",[41],"Drug: NAL ER",{"label":43,"type":38,"description":44,"interventionNames":45},"Cohort 2: NAL ER Dose B","Participants will receive NAL ER Dose B on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences.",[41],[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"DRUG","NAL ER","Oral tablets",[37,43],[53],"Nalbuphine",[55],{"name":56,"affiliation":5,"role":57},"Chief Development Officer","STUDY_DIRECTOR",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Clinical Pharmacology of Miami, LLC.","RECRUITING","Miami","Florida","33172","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-80.19366,25.77427,{"lat":71,"lon":70},[74],{"name":75,"role":76,"phone":77,"phoneExt":78,"email":79},"Hadaza Catala","CONTACT","305-817-2900","+1","hcatala@ergclinical.com",{"type":81,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100630443",false,"NCT07487740","A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants","A Randomized, Phase 1, Open-Label, Two-Treatment, Two- Period, Two-Sequence, Single-Dose Crossover Study to Evaluate the Effect of Food on the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Subjects","Inclusion Criteria:\n\n* Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg\u002Fm2) at Screening.\n* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.\n\nExclusion Criteria:\n\n* Positive results for coronavirus infection (COVID-19) at Screening or check-in (Day -1).\n* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.\n* Positive urine drug or alcohol results at Screening or check in (Day -1).\n* Smoker who has smoked or used nicotine containing products within the last 3 months prior to the first dose and throughout the study, confirmed by a negative cotinine test at Screening and check-in (Day -1).\n* History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.\n* Hemoglobin, absolute neutrophil count, or platelet levels outside of the reference range at Screening.\n* History of prolonged QT syndrome or a corrected QT (QTc) interval.\n* Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).\n* Participation in another clinical study within 5 half-lives or 30 days, whichever is longer, of the Baseline visit.\n\nNote: Other inclusion\u002Fexclusion criteria mentioned in the protocol may apply.",true,"ALL","18 Years","60 Years",{"count":93,"type":94},60,"ESTIMATED","INTERVENTIONAL",[97],"PHASE1","The primary purpose of this study is to evaluate the effect of a high-fat, high-calorie meal on the relative bioavailability of NAL ER following single oral doses.",[100],"Healthy Participants","2026-03-17",{"date":103,"type":104},"2026-03-23","ACTUAL",{"date":106,"type":104},"2026-02-27",{"date":108,"type":94},"2026-04",{"name":5,"class":6},1]