NCT07036029 NAL ER IPF Respiratory Function and Safety Study
| NCT ID | NCT07036029 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Trevi Therapeutics |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-08-21 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-08-21 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Chief Development Officer
STUDY DIRECTOR
Trevi Therapeutics
Frequently Asked Questions
Who can join the NCT07036029 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Idiopathic Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07036029 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07036029 currently recruiting?
Yes, NCT07036029 is actively recruiting participants. Contact the research team at Connie.crum@trevitherapeutics.com for enrollment information.
Where is the NCT07036029 trial being conducted?
This trial is being conducted at Rochester, United States, Manchester, United Kingdom.
Who is sponsoring the NCT07036029 clinical trial?
NCT07036029 is sponsored by Trevi Therapeutics. The principal investigator is Chief Development Officer at Trevi Therapeutics. The trial plans to enroll 10 participants.