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Completed

NCT Number: NCT07036029

NAL ER IPF Respiratory Function and Safety Study

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medicines Evaluation Unit Ltd., Manchester, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NAL ER

Drug

Oral tablets

Other names: Nalbuphine

Placebo

Drug

Oral tablets

Primary outcomes

  1. Respiratory Function and Safety Assessed by Number of Participants With Increase in End Tidal Partial Pressure of Carbon Dioxide by Capnography (PetCO2) of at Least 10 Millimetres of Mercury (mmHg) From Baseline, or PetCO2>55 mmHg, for at Least 1 Minute

    Time frame: Up to Day 6

  2. Respiratory Function and Safety as Assessed by Number of Participants With a Decrease in Blood Oxygen Saturation (SpO2) to <88% for at Least 1 Minute

    Time frame: Up to Day 6

  3. Respiratory Function and Safety as Assessed by Number of Participants With a Decrease in Respiratory Rate (RR) to <6 Breaths per Minute

    Time frame: Up to Day 6

  4. Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to Day 51

Sponsors and collaborators

Lead sponsor

Trevi Therapeutics

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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