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NOT YET RECRUITING
NCT07643155
PHASE1

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

Sponsor: Insmed Incorporated

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-06-10

Completion Date

2027-02-07

Last Updated

2026-06-11

Healthy Volunteers

Yes

Interventions

DRUG

Treprostinil Palmitil Inhalation Powder

Oral inhalation using a dry powder inhaler device.