NCT07036029

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
0mo left

Started Aug 2025

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Aug 2025Jun 2026

First Submitted

Initial submission to the registry

May 29, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 21, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

May 29, 2025

Last Update Submit

April 8, 2026

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

nalbuphine

Outcome Measures

Primary Outcomes (4)

  • Respiratory Function and Safety Assessed by Number of Participants With Increase in End Tidal Partial Pressure of Carbon Dioxide by Capnography (PetCO2) of at Least 10 Millimetres of Mercury (mmHg) From Baseline, or PetCO2>55 mmHg, for at Least 1 Minute

    Up to Day 6

  • Respiratory Function and Safety as Assessed by Number of Participants With a Decrease in Blood Oxygen Saturation (SpO2) to <88% for at Least 1 Minute

    Up to Day 6

  • Respiratory Function and Safety as Assessed by Number of Participants With a Decrease in Respiratory Rate (RR) to <6 Breaths per Minute

    Up to Day 6

  • Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Up to Day 51

Study Arms (1)

NAL ER

EXPERIMENTAL

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 ERDrug: Placebo

Interventions

NAL ERDRUG

Oral tablets

Also known as: Nalbuphine
NAL ER
PlaceboDRUG

Oral tablets

NAL ER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Medicines Evaluation Unit Ltd.

Manchester, M23 9QZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Nalbuphine

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Chief Development Officer

    Trevi Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Connie Crum

CONTACT

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

Paula Buckley

CONTACT

203-680-3864Paula.buckley@trevitherapeutics.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2025

First Posted

June 25, 2025

Study Start

August 21, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)US(1)