Treprostinil Palmitil Inhalation Powder: how liver function affects drug in a single-dose test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial examines the pharmacokinetics and safety of a single 80 mcg dose of Treprostinil Palmitil Inhalation Powder (TPIP) in adults with normal hepatic function and those with mild, moderate, or severe hepatic impairment. Participants will be grouped by liver function and receive the same dose to compare how liver disease affects drug exposure. The study collects PK data and monitors safety signals to understand whether hepatic impairment alters clearance or distribution. Lead sponsor is Insmed Incorporated with sites in California and Florida. The study aims to inform dosing considerations for TPIP in patients with varying liver function.

Why it matters

Who can join: the full rules

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.

Where it's running

• Usa004
  Lake Forest, California, United States Recruiting
• Usa003
  San Dimas, California, United States Recruiting
• Usa002
  Orlando, Florida, United States Recruiting
• Usa001
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Insmed Medical Information
• Email: medicalinformation@insmed.com
• Phone: 18444467633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.