NCT07036029CompletedPhase 1
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)
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 29 May 2025
- Start date
- 21 Aug 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Trevi Therapeutics
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT07036029
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 9
- From 21 Aug 2025 to the primary completion date, 30 Jun 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Positive results for coronavirus infection (COVID-19) at Day -2, prior to Admission to the clinical research unit (CRU).
- Currently using any overnight oxygen therapy at any level or delivered by any modality. Intermittent daytime oxygen use of any duration is allowed.
- Upper or lower respiratory tract infection within the 8 weeks prior to admission to the CRU.
Other illness
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), or an forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \<0.8.
- Clinical history of aspiration pneumonitis.
- Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
Other
- Exacerbation of IPF in the last 3 months.
- Diagnosis of sleep disordered breathing (e.g., sleep apnea).
Who the study is looking for
- Diagnosis of IPF as determined by a pulmonologist based on American Thoracic Society (ATS)/ European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Asociación Latinoamericana de Tórax (ALAT) guidelines.
- 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.
- FVC ≥ 40% of Global Lung Function Initiative (GLI) 2012 predicted values- Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medicines Evaluation Unit Ltd Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.