Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • NAL ER

    Drug

    Oral tablets

  • Placebo

    Drug

    Oral tablets

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: NAL ERExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Up to Day 6
2

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

Time frame
Up to Day 6
3

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

Time frame
Up to Day 6
4

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

Time frame
Up to Day 51

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Trevi Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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