[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595713":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":30,"locations":40,"responsibleParty":66,"collaborators":25,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":25,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Trevi Therapeutics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NAL ER","EXPERIMENTAL","Participants will receive 2 doses of placebo (placebo matching NAL ER) over 2 days followed by increasing doses of NAL ER tablets twice daily (BID) over 6 days.",[13,14],"Drug: NAL ER","Drug: Placebo",[16,22],{"type":17,"name":9,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Oral tablets",[9],[21],"Nalbuphine",{"type":17,"name":23,"description":18,"armGroupLabels":24,"otherNames":25},"Placebo",[9],null,[27],{"name":28,"affiliation":5,"role":29},"Chief Development Officer","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Connie Crum","CONTACT","203-654-3287","Connie.crum@trevitherapeutics.com",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Paula Buckley","203-680-3864","Paula.buckley@trevitherapeutics.com",[41,55],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":25},"Mayo Clinic","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-92.4699,44.02163,{"lat":53,"lon":52},{"facility":56,"status":43,"city":57,"state":25,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":25},"Medicines Evaluation Unit Ltd.","Manchester","M23 9QZ","United Kingdom","UK",{"type":50,"coordinates":62},[63,64],-2.23743,53.48095,{"lat":64,"lon":63},{"type":67,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100595713","phase-1-nal-er-ipf-respiratory-function-and-safety-study-100595713",false,"NCT07036029","NAL ER IPF Respiratory Function and Safety Study","An Open Label, In-Clinic Study to Assess Respiratory Function and Safety of Escalating Doses of Nalbuphine Extended-Release Tablets (NAL ER) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)","Inclusion criteria:\n\n* Diagnosis of IPF as determined by a pulmonologist based on American Thoracic Society (ATS)\u002F European Respiratory Society (ERS) \u002F Japanese Respiratory Society (JRS) \u002F Asociación Latinoamericana de Tórax (ALAT) guidelines.\n* SpO2 ≥ 92%, taken after at least 5 minutes in a sitting position, undisturbed and non-stimulated - Saturation of Hemoglobin with Oxygen as measured by pulse oximetry.\n* FVC ≥ 40% of Global Lung Function Initiative (GLI) 2012 predicted values- Forced Vital Capacity, as determined by spirometry adhering to ATS\u002FERS guidelines.\n\nExclusion criteria:\n\n* Exacerbation of IPF in the last 3 months.\n* Positive results for coronavirus infection (COVID-19) at Day -2, prior to Admission to the clinical research unit (CRU).\n* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), or an forced expiratory volume in 1 second (FEV1)\u002Fforced vital capacity (FVC) \\\u003C0.8.\n* Currently using any overnight oxygen therapy at any level or delivered by any modality. Intermittent daytime oxygen use of any duration is allowed.\n* Diagnosis of sleep disordered breathing (e.g., sleep apnea).\n* Upper or lower respiratory tract infection within the 8 weeks prior to admission to the CRU.\n* Clinical history of aspiration pneumonitis.\n\nNote: Other inclusion\u002Fexclusion criteria mentioned in the protocol may apply.","ALL","18 Years",{"count":78,"type":79},10,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","The primary purpose of this study is to assess the safety and tolerability of escalating doses of NAL ER and to evaluate its effect on respiratory function in participants with IPF.",[85],"Idiopathic Pulmonary Fibrosis",[87],"nalbuphine","2026-04-08",{"date":90,"type":91},"2026-04-09","ACTUAL",{"date":93,"type":91},"2025-08-21",{"date":95,"type":79},"2026-06-30",{"name":5,"class":6},2]