RecruitingPhase 1NCT07643155

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

An Open-label, Phase 1 Trial to Evaluate the Pharmacokinetics and Safety of a Single Dose of 80 μg Treprostinil Palmitil Inhalation Powder in Participants With Normal Hepatic Function and Participants With Hepatic Impairment


Sponsor

Insmed Incorporated

Enrollment

30 participants

Start Date

Jul 14, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of the study is to determine the effect of mild, moderate, and severe hepatic impairment on the PK of total treprostinil palmitil (TP) and treprostinil (TRE) following a single dose of 80 micrograms (μg) TPIP, when compared to normal hepatic function.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Treprostinil Palmitil Inhalation Powder for people with hepatic impairment. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTreprostinil Palmitil Inhalation Powder

Oral inhalation using a dry powder inhaler device.


Locations(4)

USA004

Lake Forest, California, United States

USA003

San Dimas, California, United States

USA002

Orlando, Florida, United States

USA001

San Antonio, Texas, United States

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NCT07643155


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