[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Trevi Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,61,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100644548","phase-2-the-effect-of-nalbuphine-extended-release-nal-er-on-cough-in-participants-with-refractory-chronic-cough-rcc-100644548",false,"NCT07671924","The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)","A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Participants With Refractory Chronic Cough","LAKE","Inclusion Criteria:\n\n* Meets society guideline-based criteria for a diagnosis of RCC defined as:\n\n  * Insufficient improvement in cough after treatment for any identified cough-associated conditions.\n  * Unexplained cough for which an underlying condition has not been determined despite adequate investigation with diagnostic tests and trials of therapy.\n* Persistent and chronic cough for at least one year prior to Screening.\n* Chest computed tomography (CT) or chest radiograph of the thorax performed within the last 24 months and after the onset of chronic cough OR the procedure completed by the Investigator during the Screening period, that does not show any abnormality considered to be significantly contributing to the RCC in the opinion of the Principal Investigator.\n* 24-hour objective cough frequency ≥10 coughs\u002Fhour based on VitaloJAK® cough monitor recording performed during the Screening and Placebo Run-in Periods as well as a minimum recording duration of 20 hours suitable for analysis during the placebo Run-in assessment.\n* Forced expiratory volume in 1 second (FEV1) \u002Fforced vital capacity (FVC) ratio ≥ 60% as determined by spirometry adhering to American Thoracic Society (ATS)\u002FEuropean Respiratory Society (ERS) guidelines.\n\nExclusion Criteria:\n\n* Clinical diagnosis of sleep apnea and\u002For use of continuous positive airway pressure (CPAP).\n* Upper or lower respiratory tract infection or change in pulmonary status in the 4 weeks prior to the Screening visit or during the Screening or PBO Run-in periods.\n* History of bronchiectasis, chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (IPF), or other significant respiratory disorder that might affect cough.\n* History of uncontrolled asthma defined as one of the following:\n\n  * ≥1 clinically significant exacerbation in the last 6 months, OR\n  * ≥2 clinically significant exacerbations in the past 12 months (a clinically significant asthma exacerbation is defined as requiring the use of systemic corticosteroids).\n* Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vaper.\n* Individuals who have stopped smoking or vaping within the past 6 months, or those with \\>20 pack-year smoking history.\n* Current active tuberculosis or nontuberculous mycobacterial infection, a history of latent untreated tuberculosis, or a history of incompletely treated tuberculosis.\n* Speech therapy\u002Fphysiotherapy for RCC starting within 4 weeks of Baseline or during the study. Speech therapy\u002Fphysiotherapy is acceptable if the participant has started the therapy more than 4 weeks prior to the Baseline visit AND plans to continue the therapy through the Titration and Fixed-dose Treatment Period.\n* Known intolerance \\[gastrointestinal, central nervous system (CNS) symptoms\\], hypersensitivity, or drug allergy considered to be related to an opioid drug or known hypersensitivity to nalbuphine or to NAL ER excipients.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of Nalbuphine ER Extended-release tablets for the treatment of participants with RCC.",[27],"Refractory Chronic Cough","NOT_YET_RECRUITING","2026-06-22",{"date":31,"type":32},"2026-06-26","ACTUAL",{"date":34,"type":21},"2026-06",{"date":36,"type":21},"2027-09",{"name":38,"class":39},"Trevi Therapeutics","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":60,"locationsCount":4},"100644504","phase-3-idiopathic-pulmonary-fibrosis-ipf-related-chronic-cough-reduction-with-nalbuphine-extended-release-nal-er-tablets-100644504","NCT07671911","Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis","OCEAN-1","Inclusion Criteria:\n\n* Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)\u002FEuropean Respiratory Society (ERS)\u002FJapanese Respiratory Society (JRS)\u002FLatin American Thoracic Society (ALAT) clinical practice guidelines.\n* Chronic cough for ≥8 weeks prior to Screening.\n* PGI-Severity Score ≥ 2 at Screening.\n* Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening.\n* Diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted during Screening or within 12 weeks prior to Screening.\n* Participants who are currently taking antifibrotic medication (e.g., nintedanib, pirfenidone, nerandomilast) should be on a stable dose for at least 6 weeks prior to the Baseline Visit.\n\nExclusion Criteria:\n\n* Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during Screening.\n* Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 2 months prior to Screening.\n* Diagnosed sleep apnea or currently on any treatment for sleep apnea \\[example (e.g.), Continuous Positive Airway Pressure (CPAP)\\].\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","40 Years",{"count":50,"type":21},306,[52],"PHASE3","The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with Idiopathic Pulmonary Fibrosis (IPF).",[55],"Idiopathic Pulmonary Fibrosis",{"date":31,"type":32},{"date":34,"type":21},{"date":59,"type":21},"2028-07",{"name":38,"class":39},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":72,"conditions":73,"keywords":74,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100595713","phase-1-nal-er-ipf-respiratory-function-and-safety-study-100595713","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.",{"count":69,"type":21},10,[71],"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.",[55],[75],"nalbuphine","RECRUITING","2026-04-08",{"date":79,"type":32},"2026-04-09",{"date":81,"type":32},"2025-08-21",{"date":83,"type":21},"2026-06-30",{"name":38,"class":39},2,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100630443","phase-1-a-food-effect-study-to-evaluate-the-relative-bioavailability-of-nalbuphine-extended-release-tablets-nal-er-in-healthy-participants-100630443","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,"60 Years",{"count":96,"type":21},60,[71],"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":32},"2026-03-23",{"date":105,"type":32},"2026-02-27",{"date":107,"type":21},"2026-04",{"name":38,"class":39},1,""]