NAL ER for Idiopathic Pulmonary Fibrosis

Recruiting at 1 trial location

Overseen By Paula Buckley

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Trevi Therapeutics

Disqualifiers: COPD, Sleep apnea, Aspiration pneumonitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 days

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new treatment called NAL ER, an extended-release medication, for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that makes breathing difficult. The trial aims to determine the safety of NAL ER and its effects on breathing in people with IPF. Participants will initially take a placebo, a pill with no active medicine, and then try different doses of NAL ER. This trial may suit those diagnosed with IPF who do not require overnight oxygen therapy and have not experienced a recent flare-up. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that NAL ER is likely to be safe for humans?

Previous studies have used NAL ER to treat cough in people with idiopathic pulmonary fibrosis (IPF). While the treatment reduced cough, some side effects occurred, including nausea, tiredness, constipation, and dizziness. About 23.6% of participants discontinued the drug due to these issues. This trial is in an early stage, focusing on safety and tolerability. So far, evidence suggests that although NAL ER can cause some discomfort, it is being carefully tested to ensure safety for further use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for idiopathic pulmonary fibrosis, which often focus on slowing disease progression, NAL ER offers a new approach by potentially accelerating symptom relief. Researchers are excited about NAL ER because it involves a novel dosing regimen where participants start with a placebo for two days before escalating doses of NAL ER. This method may aid in better management of the condition with possibly faster results. The twice-daily tablet form could also improve patient compliance compared to more complex treatment schedules.

What evidence suggests that NAL ER might be an effective treatment for idiopathic pulmonary fibrosis?

Research has shown that NAL ER, the treatment under study in this trial, may help reduce daytime coughing in people with idiopathic pulmonary fibrosis (IPF). In one study, 42% of patients taking NAL ER experienced a 75% reduction in cough frequency, while no one in the placebo group showed this improvement. Another study found that NAL ER quickly and significantly reduced coughing by 75.1%. Overall, patients using NAL ER have reported less daytime coughing, suggesting it could help manage IPF symptoms. Although these results are promising, further research is needed to fully understand its effects. ^{2 3 5 6 7}

Who Is on the Research Team?

Chief Development Officer

Principal Investigator

Trevi Therapeutics

Are You a Good Fit for This Trial?

This trial is for people with Idiopathic Pulmonary Fibrosis (IPF) who have a Forced Vital Capacity of at least 40% of predicted values and an oxygen saturation level above 92%. They must be diagnosed by a pulmonologist according to specific guidelines. Those with recent IPF exacerbation, overnight oxygen therapy, COVID-19 infection, COPD, respiratory infections in the last 8 weeks or sleep disordered breathing cannot participate.

Inclusion Criteria

FVC ≥ 40% of GLI 2012 predicted values- Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS 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

I have been diagnosed with IPF by a lung specialist.

Exclusion Criteria

My lung condition has worsened in the last 3 months.

I use oxygen therapy at night but may use it during the day.

Positive results for coronavirus infection (COVID-19) at Day -2, prior to Admission to the CRU

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 doses of placebo over 2 days followed by escalating doses of NAL ER tablets twice daily over 6 days

8 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NAL ER

Trial Overview

The study is testing NAL ER's safety and its impact on lung function in IPF patients compared to a placebo. Participants will receive different doses of NAL ER to determine how well it's tolerated and if it improves their ability to breathe.

How Is the Trial Designed?

Group I: NAL ER Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Trevi Therapeutics

Lead Sponsor

Trials

11

Recruited

1,400+

Citations

1.

evidence.nejm.org

evidence.nejm.org/doi/full/10.1056/EVIDoa2300083

Nalbuphine Tablets for Cough in Patients with Idiopathic ...

In conclusion, treatment with NAL ER for 3 weeks resulted in a rapid and marked reduction in recorded daytime cough among patients with IPF- ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04030026

NCT04030026 | A Study of Nalbuphine (Extended Release ...

To evaluate the safety and tolerability of nalbuphine ER tablets in the study population and to evaluate the effect of NAL ER tablets on the mean daytime ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12004257/

Cough in idiopathic pulmonary fibrosis: what is new - PMC

Results showed a rapid and significant reduction in objective daytime cough frequency during the NAL-ER treatment (75.1%) versus the placebo ...

4.

thorax.bmj.com

thorax.bmj.com/content/77/Suppl_1/A13.2

S15 Efficacy of oral nalbuphine extended release for ...

Overall, 42% of NAL ER-treated patients (vs'0% for placebo) achieved a 75% reduction in cough frequency (figure 1). Preliminary analysis of EXACT2 shows patient ...

5.

trevitherapeutics.com

trevitherapeutics.com/previous-clinical-trials/

Previous Clinical Trial Results

Haduvio™ (oral nalbuphine ER) achieved statistically significant reductions in cough frequency in patients with idiopathic pulmonary fibrosis (IPF) and in ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07036029

NAL ER IPF Respiratory Function and Safety Study

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 ...

7.

trialx.com

trialx.com/clinical-trials/listings/309702/nal-er-ipf-respiratory-function-and-safety-study/?&radius=50

NAL ER IPF Respiratory Function and Safety Study

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 ...