NAL ER IPF Respiratory Function and Safety Study
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
9actual
Sites
2
Countries
United Kingdom, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-21 | actual | When the study began enrolling |
| Primary completion | 2026-06-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-06-30 | actual | The whole study's end, after follow-up |
| First posted | 2025-06-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Idiopathic Pulmonary Fibrosis
Interventions
- Drug: NAL ER — also filed as Nalbuphine
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFRespiratory Function and Safety Assessed by Number of Participants With Increase in End Tidal Partial Pressure of Carbon Dioxide by Capnography (PetCO2) of at Least 10 Millimetres of Mercury (mmHg) From Baseline, or PetCO2>55 mmHg, for at Least 1 Minute
measured Up to Day 6
Respiratory Function and Safety as Assessed by Number of Participants With a Decrease in Blood Oxygen Saturation (SpO2) to <88% for at Least 1 Minute
measured Up to Day 6
Respiratory Function and Safety as Assessed by Number of Participants With a Decrease in Respiratory Rate (RR) to <6 Breaths per Minute
measured Up to Day 6
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)
measured Up to Day 51
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