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NCT Number: 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

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index between 18.0 and 40.0 kilograms per square meter (kg/m^2), inclusive.

Inclusion criteria

for Participants with Normal Hepatic Function

  • 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).

Inclusion criteria

for Participants With Hepatic Impairment:

  • 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.

Exclusion criteria

  • 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.

Exclusion criteria

for Participants with Normal Hepatic Function

  • 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.
  • Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in. Results that are compatible with marijuana use are not exclusionary.

Exclusion criteria

for Participants With Hepatic Impairment:

  • 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.
  • History of drug/chemical abuse within 1 year prior to check-in. Marijuana use is not exclusionary.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Treprostinil Palmitil Inhalation Powder

Drug

Oral inhalation using a dry powder inhaler device.

Other names: INS1009

Primary outcomes

  1. 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

    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.

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

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

    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.

  3. Maximum Observed Plasma Concentration (Cmax) of TP and TRE

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

Secondary outcomes

  1. Fraction Unbound (Fu) of TRE

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

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

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

    Time frame: Up to Day 7

    Evaluation of safety and tolerability of a single dose of TPIP in participants with mild, moderate, and severe hepatic impairment and normal hepatic function.

Study contacts

Contact information is provided by the study sponsor or research team.

Insmed Medical Information

CONTACT

[email protected]

18444467633

Sponsors and collaborators

Lead sponsor

Insmed Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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