Clinical Trials

Inclusion Criteria:

• Diagnosis of IPF as determined by the Investigator based on ATS/ERS/JRS/ALAT guidelines (Raghu et al, 2018; updated in Raghu et al, 2022).
• SpO2 ≥ 90%, 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 GLI 2012 predicted values (Langhammer et al, 2016)- 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.

Day -2 Inclusion Criteria:

• Pulmonary physical examination by the Investigator to rule out demonstrable unilateral pulmonary abnormality will be performed on Day -2 PRIOR to any baseline procedures.

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.
  • >300 MVpred% for 2 minutes following 5 minutes at rest
  • Currently using overnight continuous oxygen therapy at any level or delivered by any modality. Intermittent daytime oxygen use of any duration 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.
• 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
  • ≥470ms if QRS <120ms or
  • ≥500ms in the presence of either a Right Bundle Branch Block (RBBB) or QRS ≥120ms
• Kidney Function: Estimated glomerular filtration rate (eGFR) ≤44 ml/min/1.73 m2 at screening.
• Liver Function: Total Bilirubin >3mg/dL [>50umol/L] and Serum Albumin <2.8g/dl at screening.
• Subjects with a history of over sedation or a current clinical diagnosis of sedation from the use of the present chronic drug regimen as deemed by the Investigator.
• 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 and/or marijuana consumption is prohibited from 2 days prior to admission for the baseline visit, until discharge from the CRU upon completion of the off-treatment monitoring.
• Significant medical condition or other factors as assessed by the Investigator 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 Childbearing Potential (WOCBP) Pregnancy test, and contraceptive counselling.
• Known intolerance (gastrointestinal, central nervous system symptoms), hypersensitivity, drug allergy following the use of an opioid drug.
• Known hypersensitivity to nalbuphine or to any of the excipients in NAL ER.
• Concurrent or anticipated enrollment in an ongoing interventional 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. This includes opiate-containing anti-cough agents, and naltrexone. Subjects are prohibited from using opioids for the duration of the study.
• Use of barbiturates or benzodiazepines are prohibited within 14 days prior to the baseline visit and for the duration of the study.
• Use of any first-generation sedating antihistamines (Estelle and Simons, 2004 Table 3) or over the counter (OTC) or prescription sleep aids are prohibited 14 days prior to the baseline visits 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 11/26/2024. Questions regarding updates should be directed to the study team contact.