Clinical Trials

Inclusion Criteria:

• Diagnosis of IPF as determined by the Principal Investigator based on ATS/ERS/JRS/ALAT (Raghu et al, 2018; updated in Raghu et al, 2022).
• SpO2 ≥ 90%, taken after at least 5 minutes in a sitting position, undisturbed and nonstimulated - Saturation of Hemoglobin with Oxygen as measured by pulse oximetry.
• FVC ≥ 40% of predicted of normal - Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines (Graham et al, 2019).
• Males or females ages 18 years and older at the time of consent.
• Willing and able to provide written informed consent, comply with study requirements and restrictions, and agree to the confidential use and storage of all data and use of all anonymized data for publication including scientific publication.

Exclusion Criteria:

• During baseline 36-hour monitoring:
  • Meets any of the study stopping criteria;
  • Identified as having possible sleep disordered breathing based on overnight assessments;
  • > 200 MVpred% sustained following 2 minutes at rest in chair or reclined. The subject will complete the baseline phase but will be ineligible to enter the treatment phase.
• Currently using overnight continuous oxygen therapy at any level or delivered by any modality. Intermittent daytime oxygen use of any duration over any given 24-hour period is allowed.
• Diagnosis of sleep disordered breathing (e.g., sleep apnea), including patients requiring CPAP. Sleep apnea patients (including patients requiring CPAP) will be eligible for inclusion in the baseline study phase.
• Significant right side-left side disease asymmetry on chest X-Ray, chest computed tomography (CT)-scan, or respiratory examination.
• Inadequate swallow reflex as assessed by the ability to sip 3 ounces (oz)/90 ml of water without coughing or choking.
• Upper or lower respiratory tract infection within the 8 weeks prior to the baseline visit.
• Clinical history of aspiration pneumonitis.
• Cardiac Safety: Mean QTcF value of 3 screening Electrocardiograms (ECG) calculated as a) ≥ 470ms if QRS 100 beats per minute (bpm), as determined by vital signs pulse over 30-60 seconds:
  • Subjects with a resting heart rate of 100 bpm should be considered a screen failure. Rescreening may be possible with the approval of the medical monitor, after medical or alternative management of the atrial fibrillation.
• Kidney Function: Estimated glomerular filtration rate (eGFR) ≤ 44 ml/min/1.73 m^2 at screening.
• Liver Function: Total Bilirubin > 3mg/dL [ > 50umol/L] and Serum Albumin < 2.8g/dl at screening.
• History of major psychiatric disorder, which in the opinion of the Investigator, could interfere with the assessment of respiratory function and/or safety events during the study or with the ability of the subject to cooperate with study requirements.
• History of substance abuse, including excessive alcohol consumption, that in the opinion of the investigator, may interfere with the conduct of the study. Alcohol consumption is prohibited from 2 days prior to admission for the baseline visit, until discharge after the treatment period.
• Significant medical condition or other factors that may interfere with the subject’s ability to successfully complete the study.
• Pregnant or lactating female subject. Women of childbearing potential (WOCBP) must use an acceptable method of birth control and have a negative pregnancy test at the screening and baseline visits. WOCBP and acceptable methods of birth control are defined in the protocol, Section 8.29 Women of Child Bearing Potential (WOCBP) Pregnancy test, and contraceptive counselling.
• Known intolerance (gastrointestinal, central nervous system symptoms), hypersensitivity, drug allergy following the use of an opioid drug.
• Concurrent enrollment in an ongoing clinical trial or anticipated enrollment in a concurrent clinical trial. Observational or long-term safety follow-up studies (e.g., in a vaccine study) may be allowed upon medical monitor approval.

Medication-related Exclusions:

• Use of opiates (including opiate containing cough suppressants) is prohibited within 14 days prior to the baseline visit. Includes opiate-containing anti-cough agents, and naltrexone. Subjects are prohibited from using opioids for the duration of the study.
• 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.
• 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.
• Strong inhibitors/inducers of the P450 Isozymes are prohibited unless on a stable dose for 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/19/23. Questions regarding updates should be directed to the study team contact.