Actively Recruiting
Phase 1 Study of a Single 80 mcg Dose of Treprostinil Palmitil Inhalation Powder in Adults With Normal or Impaired Liver Function
Led by Insmed Incorporated · Updated on 2026-08-11
30
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of different levels of liver impairment on how the body processes treprostinil palmitil and treprostinil after a single dose of 80 micrograms of Treprostinil Palmitil Inhalation Powder TPIP. This Phase 1 trial aims to compare people with normal liver function to those with mild, moderate, or severe hepatic impairment to understand the drugs pharmacokinetics. Participants are divided into four groups based on liver function normal, mild, moderate, and severe impairment. Each participant receives one dose of TPIP by oral inhalation using a dry powder inhaler device on Day 1. The study monitors drug levels and safety after this single dose, with no placebo or randomization involved. During the study, participants undergo blood sampling at multiple timepoints up to three days after dosing to measure drug concentration and metabolism. Researchers also track adverse events up to seven days after dosing. Participants are assessed for eligibility with health evaluations and laboratory tests before receiving the dose. The total participation time includes screening, dosing, and follow-up assessments.
CONDITIONS
Brief Title
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index between 18.0 and 40.0 kilograms per square meter (kg/m²), inclusive.
- For normal hepatic function: Good health with no significant medical issues as shown by medical history, physical exam, ECG, vital signs, and lab tests.
- For hepatic impairment: Chronic stable hepatic impairment for more than 6 months with no significant recent changes.
- For participants with type 2 diabetes: HbA1C ≤8.5% and fasting glucose ≤240 mg/dL while on usual diabetes medication.
You will not qualify if you...
- History of stomach or intestinal surgery that could affect drug absorption or excretion, except uncomplicated appendectomy, cholecystectomy, or hernia repair.
- Use or planned use of moderate or strong CYP2C8 or CYP2C9 inducers or inhibitors within 30 days before dosing.
- Participation in another investigational drug trial within 30 days or 5 half-lives of that drug prior to dosing.
- For normal hepatic function: Significant history or signs of metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorders.
- Positive hepatitis or HIV test (except if consistent with prior immunization).
- Positive urine drug or alcohol test at screening or check-in (marijuana use allowed).
- For hepatic impairment: Current or planned organ transplant during the trial.
- Hospitalization for hepatic encephalopathy within 3 months prior to dosing.
- Encephalopathy Grade 2 or higher.
- History of drug or chemical abuse within 1 year before check-in (marijuana use allowed).
Research Team
I
Insmed Medical Information
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