RECRUITING

NAL ER IPF Respiratory Function and Safety Study

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Conditions

Idiopathic Pulmonary Fibrosisnalbuphine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open Label, In-Clinic Study to Assess Respiratory Function and Safety of Escalating Doses of Nalbuphine Extended-Release Tablets (NAL ER) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Quick Facts

Study Start:2025-06
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07036029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * FVC ≥ 40% of Global Lung Function Initiative (GLI) 2012 predicted values- Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines.
  1. * Exacerbation of IPF in the last 3 months.
  2. * Positive results for coronavirus infection (COVID-19) at Day -2, prior to Admission to the clinical research unit (CRU).
  3. * Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), or an forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \<0.8.
  4. * Currently using any overnight oxygen therapy at any level or delivered by any modality. Intermittent daytime oxygen use of any duration is allowed.
  5. * Diagnosis of sleep disordered breathing (e.g., sleep apnea).
  6. * Upper or lower respiratory tract infection within the 8 weeks prior to admission to the CRU.
  7. * Clinical history of aspiration pneumonitis.

Contacts and Locations

Study Contact

Connie Crum
CONTACT
203-654-3287
Connie.crum@trevitherapeutics.com
Paula Buckley
CONTACT
203-680-3864
Paula.buckley@trevitherapeutics.com

Principal Investigator

Chief Development Officer
STUDY_DIRECTOR
Trevi Therapeutics

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Trevi Therapeutics

  • Chief Development Officer, STUDY_DIRECTOR, Trevi Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06
Study Completion Date2025-10

Study Record Updates

Study Start Date2025-06
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • nalbuphine

Additional Relevant MeSH Terms

  • Idiopathic Pulmonary Fibrosis