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NAL ER for Idiopathic Pulmonary Fibrosis (IPF) Respiratory Function and Safety Study

This study is testing a new oral tablet called NAL ER for people with Idiopathic Pulmonary Fibrosis (IPF), a lung disease that causes scarring of the lungs. Researchers want to see how safe NAL ER is and how well it affects your breathing compared to a placebo (an inactive pill). You might be able to join if you are an adult diagnosed with IPF by a lung doctor and have a blood oxygen level (SpO2) of 92% or higher. The study will look for changes in your breathing, such as your carbon dioxide levels, oxygen levels, and breathing rate. The current status of this study is unclear, and it plans to enroll 10 participants.

Study design
This is an interventional study comparing NAL ER oral tablets to placebo oral tablets. It plans to enroll 10 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess respiratory function and safety for up to 6 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07036029

NAL ER IPF Respiratory Function and Safety Study

Completed
PHASE1Ages 18+InterventionalTreatment
Trevi Therapeutics
~9 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:NAL ERPlacebo

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Up to Day 6
+3 more outcomes measured

Conditions

Idiopathic Pulmonary Fibrosis

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Idiopathic Pulmonary Fibrosis

NCT07036029

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Rochester, Minnesotano site contact published

  • Medicines Evaluation Unit Ltd.

    Manchester, United Kingdomno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Chief Development Officer · STUDY_DIRECTOR · Trevi Therapeutics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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 MinuteUp to Day 6
  • Respiratory Function and Safety as Assessed by Number of Participants With a Decrease in Blood Oxygen Saturation (SpO2) to <88% for at Least 1 MinuteUp to Day 6
  • Respiratory Function and Safety as Assessed by Number of Participants With a Decrease in Respiratory Rate (RR) to <6 Breaths per MinuteUp to Day 6
  • Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)Up to Day 51