Actively Recruiting
NAL ER IPF Respiratory Function and Safety Study
Led by Trevi Therapeutics · Updated on 2026-04-09
10
Participants Needed
2
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NAL ER IPF Respiratory Function and Safety Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Idiopathic Pulmonary Fibrosis by a pulmonologist according to ATS/ERS/JRS/ALAT guidelines
- Blood oxygen saturation (SpO2) of 92% or higher after sitting undisturbed for at least 5 minutes
- Forced Vital Capacity (FVC) of 40% or more of predicted values according to GLI 2012, measured by spirometry following ATS/ERS guidelines
You will not qualify if you...
- Recent exacerbation of IPF within the last 3 months
- Positive COVID-19 test at Day -2 before admission to the clinical research unit
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or FEV1/FVC ratio less than 0.8
- Current use of any overnight oxygen therapy (intermittent daytime oxygen use allowed)
- Diagnosis of sleep disordered breathing such as sleep apnea
- Upper or lower respiratory tract infection within 8 weeks before admission
- History of aspiration pneumonitis
- Other criteria as noted in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Medicines Evaluation Unit Ltd.
Manchester, United Kingdom, M23 9QZ
Actively Recruiting
Research Team
C
Connie Crum
CONTACT
P
Paula Buckley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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