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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAL ER | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAL ER | Drug | Oral tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 Blood Oxygen Saturation (SpO2) to <88% 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 |
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Inclusion criteria:
Exclusion criteria:
Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Connie Crum | Contact | 203-654-3287 | Connie.crum@trevitherapeutics.com | |
| Paula Buckley | Contact | 203-680-3864 | Paula.buckley@trevitherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Chief Development Officer | Trevi Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States | |
| Medicines Evaluation Unit Ltd. |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
Oral tablets |
|
| Recruiting |
| Manchester |
| M23 9QZ |
| United Kingdom |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |