NAL ER IPF Respiratory Function and Safety Study

Purpose

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.

Condition

  • Idiopathic Pulmonary Fibrosis

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NAL ER
Participants will receive 2 doses of placebo (placebo matching NAL ER) over 2 days followed by increasing doses of NAL ER tablets twice daily (BID) over 6 days.
  • Drug: NAL ER
    Oral tablets
    Other names:
    • Nalbuphine
  • Drug: Placebo
    Oral tablets

Recruiting Locations

More Details

NCT ID
NCT07036029
Status
Recruiting
Sponsor
Trevi Therapeutics

Study Contact

Connie Crum
203-654-3287
Connie.crum@trevitherapeutics.com