NAL ER IPF Respiratory Function and Safety Study
ConditionIdiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTrevi Therapeutics
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- NAL ER
- Placebo
Treatment groups
10 Participants
are divided into 1 treatment groupLocations
2United Kingdom
Medicines Evaluation Unit Ltd.M23 9QZ, Manchester United Kingdom
United States
Mayo Clinic55905, RochesterMinnesota, United States
Sponsors and collaborators
Trevi Therapeutics
Lead sponsor
Source ClinicalTrials.gov