NAL ER IPF Respiratory Function and Safety Study
- Registration Number
- NCT07036029
- Lead Sponsor
- Trevi Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NAL ER NAL ER Participants will receive 2 doses of placebo (placebo matching NAL ER) over 2 days followed by increasing doses of NAL ER tablets twice daily (BID) over 6 days. NAL ER Placebo Participants will receive 2 doses of placebo (placebo matching NAL ER) over 2 days followed by increasing doses of NAL ER tablets twice daily (BID) over 6 days.
- Primary Outcome Measures
Name Time Method 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 Up to Day 6 Respiratory 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 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 Up to Day 6 Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) Up to Day 51
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Medicines Evaluation Unit Ltd.
🇬🇧Manchester, United Kingdom
Mayo Clinic🇺🇸Rochester, Minnesota, United States