[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630443":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":31,"responsibleParty":53,"collaborators":30,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":30,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":30,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":30,"overallStatus":34,"whyStopped":30,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Trevi Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: NAL ER",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","NAL ER","Oral tablets",[9,15],[25],"Nalbuphine",[27],{"name":28,"affiliation":5,"role":29},"Chief Development Officer","STUDY_DIRECTOR",null,[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Clinical Pharmacology of Miami, LLC.","RECRUITING","Miami","Florida","33172","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-80.19366,25.77427,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Hadaza Catala","CONTACT","305-817-2900","+1","hcatala@ergclinical.com",{"type":54,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100630443","phase-1-a-food-effect-study-to-evaluate-the-relative-bioavailability-of-nalbuphine-extended-release-tablets-nal-er-in-healthy-participants-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":67,"type":68},60,"ESTIMATED","INTERVENTIONAL",[71],"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.",[74],"Healthy Participants","2026-03-17",{"date":77,"type":78},"2026-03-23","ACTUAL",{"date":80,"type":78},"2026-02-27",{"date":82,"type":68},"2026-04",{"name":5,"class":6},1]