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 | Recruiting Phase 1 FDA Drug

• 1 other identifier: INS1009-104
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (7)

• Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Treprostinil Palmitil (TP) and Treprostinil (TRE)

  Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.

  Pre-dose and at multiple timepoints post-dose up to Day 3

• Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of TP and TRE

  Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.

  Pre-dose and at multiple timepoints post-dose up to Day 3

• Maximum Observed Plasma Concentration (Cmax) of TP and TRE

  Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.

  Pre-dose and at multiple timepoints post-dose up to Day 3

• Apparent Total Clearance (CL/F) of TP and TRE

  Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.

  Pre-dose and at multiple timepoints post-dose up to Day 3

• Apparent Terminal Elimination Half-Life (t1/2) of TP and TRE

  Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.

  Pre-dose and at multiple timepoints post-dose up to Day 3

• Time to Maximum Observed Concentration (Tmax) of TP and TRE

  Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.

  Pre-dose and at multiple timepoints post-dose up to Day 3

• Apparent Volume of Distribution (Vz/F) of TP and TRE

  Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.

  Pre-dose and at multiple timepoints post-dose up to Day 3

Secondary Outcomes (2)

• Fraction Unbound (Fu) of TRE

  Pre-dose and at multiple timepoints post-dose on Days 1 and 2

• Number of Participants Who Experienced At Least One Adverse Event (AE)

  Up to Day 7

Study Arms (4)

Group 1: Treprostinil Palmitil Inhalation Powder

EXPERIMENTAL

Healthy participants with normal hepatic function will receive a single dose of TPIP on Day 1.

Drug: Treprostinil Palmitil Inhalation Powder

Group 2: Treprostinil Palmitil Inhalation Powder

EXPERIMENTAL

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.

Drug: Treprostinil Palmitil Inhalation Powder

Group 3: Treprostinil Palmitil Inhalation Powder

EXPERIMENTAL

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.

Drug: Treprostinil Palmitil Inhalation Powder

Group 4: Treprostinil Palmitil Inhalation Powder

EXPERIMENTAL

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.

Drug: Treprostinil Palmitil Inhalation Powder

Interventions

Treprostinil Palmitil Inhalation Powder DRUG

Oral inhalation using a dry powder inhaler device.

Also known as: INS1009

Group 1: Treprostinil Palmitil Inhalation Powder; Group 2: Treprostinil Palmitil Inhalation Powder; Group 3: Treprostinil Palmitil Inhalation Powder; Group 4: Treprostinil Palmitil Inhalation Powder

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index between 18.0 and 40.0 kilograms per square meter (kg/m\^2), inclusive.
• In good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), and vital signs measurements, and clinical laboratory assessments (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in, as assessed by the investigator (or designee).
• Diagnosis of chronic (\>6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history.
• Participants with type 2 diabetes mellitus may be included, if they have:
• glycosylated hemoglobin A1C ≤8.5% at screening
• fasting blood glucose ≤240 milligrams per deciliter (mg/dL), while participant is using their normal diabetes medication, at screening and check-in.

You may not qualify if:

• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair are allowed).
• Use or intend to use any moderate or strong inducers or inhibitors of CYP2C8 or CYP2C9 within 30 days prior to dosing.
• Participation in a clinical trial involving administration of an investigational medicinal product (IMP) (new chemical entity) in the past 30 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer.
• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
• Positive hepatitis panel and/or positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.
• Current organ transplant or waiting for organ transplant scheduled to occur during the trial.
• Hospitalization for hepatic encephalopathy within 3 months prior to dosing.
• Encephalopathy ≥Grade 2.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (4)

USA004

Lake Forest, California, 92630, United States

RECRUITING

USA003

San Dimas, California, 91773, United States

RECRUITING

USA002

Orlando, Florida, 32809, United States

RECRUITING

USA001

San Antonio, Texas, 78215, United States

RECRUITING

Study Officials

• Study Director

  Insmed Incorporated

  STUDY DIRECTOR

Central Study Contacts

Insmed Medical Information

CONTACT

18444467633; medicalinformation@insmed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): February 7, 2027
• Study Completion (Estimated): February 7, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)