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A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough

Study Purpose

To investigate the efficacy and safety of Nalbuphine ER (NAL ER) tablets in subjects diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and evaluate it's treatment of cough in these patients. This is a two-treatment, 2-period crossover study. Subjects will be randomized in Treatment Period 1 to either NAL ER or matching placebo and evaluate for approximately 21 days. After completion of the first phase, subjects who received NAL ER will crossover to placebo and subjects who received placebo will crossover to NAL ER to complete Treatment Period 2.

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 - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Individuals diagnosed with Idiopathic Pulmonary Fibrosis. 2. Chronic cough > 8 weeks. 3. Daytime cough severity score ≥ 4 on Cough Severity Numerical Rating Scale at screening.

Exclusion Criteria:

1. The following conditions are excluded: 1. Interstitial lung disease (ILD) known to be caused by domestic and occupational environmental exposures. 2. Interstitial lung disease (ILD) known to be caused by connective tissue disease. 3. Interstitial lung disease (ILD) known to be caused by drug related toxicity. 2. Currently on continuous oxygen therapy. 3. History of substance abuse that, as determined by the Investigator, may interfere with the conduct of the study

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.	NCT04030026
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.	Thomas Sciascia
Principal Investigator Affiliation	Trevi Therapeutics, Inc
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Nalbuphine, Idiopathic Pulmonary Fibrosis, Cough

Additional Details

This is a double-blind, randomized, placebo-controlled, 2-treatment, 2-period crossover efficacy and safety study in IPF subjects with NAL ER tablets for the treatment of cough. The study consists of 2 treatment periods of 3 weeks, each followed by a washout period of 2 weeks. Treatment Period 1: During Treatment Period 1, eligible subjects will be randomized (1:1) to one of the following treatment arms:

- Arm 1: Active NAL ER followed by crossover Placebo in Treatment Period 2.

- Arm 2: Placebo followed by crossover NAL ER in Treatment Period 2.

Following 3 weeks of dosing in Treatment Period 1, subjects will complete a 2-week washout period before entering Treatment Period 2. Subjects assigned to Arm 1 will receive placebo and subjects assigned to Arm 2 will receive NAL ER during Treatment Period 2. A final 2-week washout period will occur at the completion of Treatment Period 2. NAL ER Dosing Subjects on NAL ER will have the dose titrated from 27 mg once daily (QD) to 54 mg BID over a 5-day period and then maintained at 54 mg BID for approximately 4 days. Doses will be subsequently escalated and maintained at 108 mg BID over 1 week and then to 162 mg BID over 6 days.

Arms & Interventions

Arms

Active Comparator: Arm 1a: Nalbuphine ER

Active tablets containing the study drug being tested (NAL ER) twice a day for Treatment Period 1

Placebo Comparator: Arm 2a: Placebo

Placebo twice a day for Treatment Period 1

Placebo Comparator: Arm 1b: Placebo

Placebo twice a day for Treatment Period 1

Active Comparator: Arm 2b: Nalbuphine ER

Active tablets containing the study drug being tested (NAL ER) twice a day for Treatment Period 2

Interventions

Drug: - Nalbuphine ER

Subjects on NAL ER will have the dose titrated from 27 mg once daily (QD) to 54 mg BID over a 5-day period and then maintained at 54 mg BID for approximately 4 days. Doses will be subsequently escalated and maintained at 108 mg BID over 1 week and then to 162 mg BID over 6 days.

Drug: - Placebo oral tablet

Placebo Comparative will be given in Arm 1b and again in Arm 2a

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

11, Antrim, Northern Ireland, United Kingdom

Status

Recruiting

Address

Antrim, Northern Ireland, BT9 7AB

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