CompletedPhase 1

NAL ER IPF Respiratory Function and Safety Study

United States, United Kingdom9 participantsStarted 2025-08-21

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Timeframe: Up 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 Minute

Timeframe: Up to Day 6

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

Timeframe: Up to Day 6

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

Timeframe: Up to Day 51

Trial details

NCT IDNCT07036029

SponsorTrevi Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Idiopathic Pulmonary Fibrosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: Up 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 Minute

Timeframe: Up to Day 6

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

Timeframe: Up to Day 6

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

Timeframe: Up to Day 51