drugset / Trial / NCT07643155

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

NCT07643155 ↗

Phase 1 Not yet recruiting 30 enrolled Insmed Incorporated
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-06-10
Primary completion
2027-02-07
Completion
2027-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Treprostinil Palmitil Small molecule 80 ug Inhaled

Indications

No indication recorded.