At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- NAL ER (drug), Placebo (drug)
- How long the study runs
- Study runs about 10 months (dates as stated)
- About the drug or intervention
- NAL ER — drug: Oral tablets · Placebo — drug: Oral tablets
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 9
- Started
- 2025-08-21
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for idiopathic pulmonary fibrosis
- • Phase1 - 9 participants
- • 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 participants with IPF
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with idiopathic pulmonary fibrosis
Where?
- • Manchester - Medicines Evaluation Unit Ltd.
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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 participants with IPF.
Idiopathic Pulmonary Fibrosis
How this trial compares with your answers
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What we know so far
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓SpO2 ≥ 92%, taken after at least 5 minutes in a sitting position, undisturbed and non-stimulated - Saturation of...
- ✓FVC ≥ 40% of Global Lung Function Initiative (GLI) 2012 predicted values- Forced Vital Capacity, as determined by...
Who cannot take part
- ✗Exacerbation of IPF in the last 3 months.
- ✗Positive results for coronavirus infection (COVID-19) at Day -2, prior to Admission to the clinical research unit (CRU).
- ✗Diagnosis of Chronic Obstructive lung Disease (COPD), or an forced expiratory volume in 1 second (FEV1)/forced...
- ✗Currently using any overnight oxygen therapy at any level or delivered by any modality. Intermittent daytime oxygen...
- ✗Diagnosis of sleep disordered breathing (e.g., sleep apnea).
See the full criteria
Inclusion criteria:
* Diagnosis of IPF as determined by a pulmonologist based on American Thoracic Society (ATS)/ European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Asociación Latinoamericana de Tórax (ALAT) 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.
* FVC ≥ 40% of Global Lung Function Initiative (GLI) 2012 predicted values- Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines.
Exclusion criteria:
* Exacerbation of IPF in the last 3 months.
* Positive results for coronavirus infection (COVID-19) at Day -2, prior to Admission to the clinical research unit (CRU).
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), or an forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \<0.8.
* Currently using any overnight 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).
* Upper or lower respiratory tract infection within the 8 weeks prior to admission to the CRU.
* Clinical history of aspiration pneumonitis.
Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
Where Is This Study? (1 UK site)
Medicines Evaluation Unit Ltd.
Manchester M23 9QZ, United Kingdom
Data sourced from ClinicalTrials.gov · Last verified: 2026-07