Liver health may change how body handles inhaled lung drug
NCT ID NCT07643155
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This phase 1 trial investigates how mild, moderate, and severe liver impairment affects the way the body processes a single inhaled dose of treprostinil palmitil, a drug used for certain lung conditions. The study enrolls about 30 adults with varying levels of liver function and measures drug levels in the blood over time. The goal is to understand if liver problems require dose adjustments, not to test the drug's effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- treprostinil palmitil inhalation powder
- What this could lead to
- If successful, this study could help doctors determine safe dosing of treprostinil palmitil for people with liver problems.
- What could go wrong
- This is a small, early-phase trial focused on drug processing, not treatment effectiveness. Results may not apply to all patients or lead to changes in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Body mass index between 18.0 and 40.0 kilograms per square meter (kg/m\^2), inclusive. Inclusion Criteria for Participants with Normal Hepatic Function * In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements, and clinical laboratory assessments (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in, as assessed by the investigator (or designee). Inclusion Criteria for Participants With Hepatic Impairment: * Diagnosis of chronic (\>6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history. * Participants with type 2 diabetes mellitus may be included, if they have: * glycosylated hemoglobin A1C ≤8.5% at screening * fasting blood glucose ≤240 milligrams per deciliter (mg/dL), while participant is using their normal diabetes medication, at screening and check-in. Exclusion Criteria: * History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair are allowed). * Use or intend to use any moderate or strong inducers or inhibitors of CYP2C8 or CYP2C9 within 30 days prior to dosing. * Participation in a clinical trial involving administration of an investigational medicinal product (IMP) (new chemical entity) in the past 30 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer. Exclusion Criteria for Participants with Normal Hepatic Function * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). * Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included. * Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in. Results that are compatible with marijuana use are not exclusionary. Exclusion Criteria for Participants With Hepatic Impairment: * Current organ transplant or waiting for organ transplant scheduled to occur during the trial. * Hospitalization for hepatic encephalopathy within 3 months prior to dosing. * Encephalopathy ≥Grade 2. * History of drug/chemical abuse within 1 year prior to check-in. Marijuana use is not exclusionary. Note: Other protocol-defined inclusion/exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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USA001
RECRUITINGSan Antonio, Texas, 78215, United States
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USA002
RECRUITINGOrlando, Florida, 32809, United States
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USA003
RECRUITINGSan Dimas, California, 91773, United States
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USA004
RECRUITINGLake Forest, California, 92630, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a damaged liver change how a new drug works?
- Liver health and drug processing: a closer look at casdatifan
- Liver function may change how belapectin works in the body
- Liver function may change how ammoxetine works