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Cough Reduction in IPF With Nalbuphine ER

Study Purpose

This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study of nalbuphine ER (NAL ER). After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1) to one of four treatment arms.

- Arm 1: Placebo.

- Arm 2: 27 mg nalbuphine ER.

- Arm 3: 54 mg nalbuphine ER.

- Arm 4: 108 mg nalbuphine ER.

Each arm will be titrated to their fixed dose during the blinded 2-week Titration period followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of IPF as determined by the Principal Investigator based on ATS/ERS/JRS/ALAT guidelines.

- Cough Severity Score ≥ 4 on CS-NRS (Cough Severity Numerical Rating Scale) during the Screening period and Baseline.

- History of chronic cough for at least 8 weeks before screening.

- 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% predicted of normal - Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines.

- DLCO ≥ 25% predicted of normal - Diffusing capacity of the lung for carbon monoxide corrected for hemoglobin, assessed within the last 12 weeks, or at the time of screening.

Exclusion Criteria:

- Currently on continuous oxygen therapy for longer than 16 hours at any level or delivered by any modality.

Intermittent oxygen use of any duration over any given 24-hour period is allowed.

- Inadequate swallow reflex as assessed by the ability to sip 3 fluid oz (or 89 mL) of water without coughing or choking.

- Upper or lower respiratory tract infection in the last 8 weeks prior to the baseline visit.

- Clinical history of aspiration pneumonitis.

- Diagnosis of sleep apnea.

- Abnormal kidney or liver functions based on Screening lab results.

- Known hypersensitivity to nalbuphine or to NAL ER excipients.

- History of major psychiatric disorder.

- History of substance abuse.

- Significant medical condition or other factors that may interfere with the subject's ability to successfully complete the study.

- Pregnant or lactating female subject.

- Known intolerance (gastrointestinal, central nervous system symptoms), hypersensitivity, drug allergy following the use of an opioid drug.

- Use of opiates is prohibited within 14 days prior to the baseline visit.

- Use of benzodiazepines are prohibited within 14 days prior to the baseline visit and for the duration of the study.

- Monoamine oxidase inhibitors (MAOIs) including methylene blue (methylthioninium chloride) and the antibiotic linezolid are prohibited within 14 days prior to the baseline visit and for the duration of the study.

- Use of oral corticosteroid cough treatment is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.

- Exposure to any investigational medication, including placebo, is prohibited within 4 weeks prior to the baseline visit and for the duration of the study.

- Medications prescribed as cough suppressants are prohibited unless on a stable dose 14-days prior to the baseline visit and are expected to remain on that dose for the duration of the study.

- Use of medications that affect serotonergic neurotransmission and that when used concomitantly with opioids can increase the risk of serotonin syndrome are prohibited unless on a stable dose 14-days prior to the baseline visit and are expected to remain on that dose for the duration of the study.

- Anti-fibrotic medications are prohibited unless on a stable dose for 8 weeks prior to the baseline visit and are expected to remain on that dose for the duration of the study.

- Strong inhibitors/inducers of the P450 Isozymes are prohibited unless on a stable dose for 14-days prior to baseline visit and are expected to remain on that dose for the duration of the study.

- Use of a medication having a "known risk" of Torsade de Pointes (categorized as "KR" on the Credible Meds® website.

) 4 weeks prior to Baseline.

- Use of unstable doses of medications associated with a potential risk of QT prolongation but not clearly associated with Torsade de Pointes within 4 weeks of screening.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05964335
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Trevi Therapeutics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	David Clark, MD
Principal Investigator Affiliation	Trevi Therapeutics
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Canada, Chile, Germany, Italy, Netherlands, Poland, Spain, Turkey, United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Additional Details

This is a multi-center randomized, double-blind, placebo-controlled, parallel, 4-arm study. After meeting eligibility during the Screening Period, subjects will be randomized (1:1:1:1) to one of four treatment arms.

- Arm 1: Placebo.

- Arm 2: 27 mg nalbuphine ER.

- Arm 3: 54 mg nalbuphine ER.

- Arm 4: 108 mg nalbuphine ER.

Each arm will be titrated to their fixed dose during the blinded 2-week Titration period according to Table: Dosing Scheme, followed by the 4-week Fixed Dose Period for a total of 6 weeks on drug. Subjects will be taken off study drug at the end of the Fixed Dose Period and followed off treatment for an additional 2 weeks.

Arms & Interventions

Arms

Experimental: NAL ER 27 mg

BID

Experimental: NAL ER 54 mg

BID

Experimental: NAL ER 108 mg

BID

Placebo Comparator: Placebo

Placebo, tablets BID

Interventions

Drug: - nalbuphine ER 27 mg

Oral tablets

Drug: - Placebo

Oral tablets

Drug: - nalbuphine ER 54 mg

Oral Tablets

Drug: - nalbuphine ER 108 mg

Oral tablets

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Eastern Health-Box Hill Hospital, Box Hill, Australia

Status

Not yet recruiting

Address

Eastern Health-Box Hill Hospital

Box Hill, , 3128

Site Contact

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Cough Reduction in IPF With Nalbuphine ER

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Exclusion Criteria:

Trial Details

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