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

Part of paid clinical trials in Lake Forest, California.

Sponsor
Insmed Incorporated
Study ID
NCT07643155
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Treprostinil Palmitil Inhalation Powder — DRUG
    Oral inhalation using a dry powder inhaler device.

Study Details

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.

Key Dates

First listed
Jun 11, 2026
Start date
Jul 14, 2026
Status verified
Aug 2026
Primary completion
Feb 7, 2027
Completion
Feb 7, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Treprostinil Palmitil Inhalation Powder
    Healthy participants with normal hepatic function will receive a single dose of TPIP on Day 1.
  • Experimental: Group 2: Treprostinil Palmitil Inhalation Powder
    Participants with mild hepatic impairment (classified based on the numerical Child-Pugh total score of 5 to 6) will receive a single dose of TPIP on Day 1.
  • Experimental: Group 3: Treprostinil Palmitil Inhalation Powder
    Participants with moderate hepatic impairment (classified based on the numerical Child-Pugh total score of 7 to 9) will receive a single dose of TPIP on Day 1.
  • Experimental: Group 4: Treprostinil Palmitil Inhalation Powder
    Participants with severe hepatic impairment (classified based on the numerical Child-Pugh total score of 10 to 15) will receive a single dose of TPIP on Day 1.

Primary Outcome Measure

Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Treprostinil Palmitil (TP) and Treprostinil (TRE) [ Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 3 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Orlando County Research CenterLake ForestCalifornia92630-
Orange Clinical Research CenterOrlandoFlorida32809-

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By research site
Orlando County Research Center· Lake Forest, CAOrange Clinical Research Center· Orlando, FL

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