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Hepatic ImpairmentHealthy volunteersDrugPhase 1

What this study is

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.

What's being tested

  • Treprostinil Palmitil Inhalation Powder

    Intervention · DRUG

    Oral inhalation using a dry powder inhaler device.

Study details

Official title
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
Conditions
Hepatic Impairment
Enrolling
30 people
Starts
2026-07-14
Est. completion
2027-02-07
Design
Open-label, non-randomized, parallel groups, Phase 1
Record
View on ClinicalTrials.gov ↗