NAL ER for breathing function and safety in idiopathic pulmonary fibrosis

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)

This trial will test whether NAL ER is safe and how it affects breathing in people with idiopathic pulmonary fibrosis (IPF).

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Trevi Therapeutics (Industry-sponsored)
• Locations: 2 sites (Rochester, Minnesota and 1 other locations)
• Trial ID: NCT07036029 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, randomized, placebo-controlled study testing escalating doses of extended-release nalbuphine (NAL ER) in adults with IPF to characterize safety and effects on respiratory function. Participants will receive NAL ER or placebo and undergo monitoring of oxygen saturation and spirometry, including forced vital capacity (FVC), under controlled clinical research unit conditions. Key entry requirements include a pulmonologist-confirmed IPF diagnosis by ATS/ERS/JRS/ALAT guidelines, resting SpO2 ≥ 92%, and FVC ≥ 40% predicted, while recent exacerbation, COPD, positive COVID-19, or overnight oxygen use exclude participation. The study is being conducted at the Mayo Clinic (Rochester, MN) and a Medicines Evaluation Unit in Manchester, with inpatient visits for dosing escalation and close safety monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults with a guideline-confirmed diagnosis of IPF who have resting SpO2 ≥ 92%, FVC ≥ 40% predicted, no recent IPF exacerbation, are not on overnight oxygen, and do not have COPD.

Not a fit: Patients with advanced disease who require overnight oxygen, have FVC below entry criteria, recent exacerbation, COPD, or active COVID-19 are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, NAL ER could provide a safe treatment option that helps stabilize or improve breathing symptoms for people with IPF.

How similar studies have performed: This approach is relatively novel for IPF: nalbuphine ER has limited prior testing for respiratory function in IPF, although opioids have been used for breathlessness in other lung diseases with mixed results.

Eligibility criteria

Inclusion criteria:

* 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.

Exclusion criteria:

* Exacerbation of IPF in the last 3 months.
* Positive results for coronavirus infection (COVID-19) at Day -2, prior to Admission to the clinical research unit (CRU).
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), or an forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \<0.8.
* Currently using any overnight oxygen therapy at any level or delivered by any modality. Intermittent daytime oxygen use of any duration is allowed.
* Diagnosis of sleep disordered breathing (e.g., sleep apnea).
* Upper or lower respiratory tract infection within the 8 weeks prior to admission to the CRU.
* Clinical history of aspiration pneumonitis.

Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.

Where this trial is running

Rochester, Minnesota and 1 other locations

• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Medicines Evaluation Unit Ltd. — Manchester, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Connie Crum

Conditions Idiopathic Pulmonary Fibrosis; nalbuphine