Recruiting
Phase 1

Treprostinil

Sponsor:

Insmed Incorporated

Code:

NCT07643155

Conditions

Hepatic Impairment

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Treprostinil Palmitil Inhalation Powder

Study Details

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

Study ID

NCT07643155

Start date

Jul 14, 2026

Status verified date

Sep, 2026

Completion date

Feb 7, 2027

Anticipated

Primary completion date

Feb 7, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Treprostinil Palmitil Inhalation Powder

Oral inhalation using a dry powder inhaler device.

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 ]
  • 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 ]
  • Maximum Observed Plasma Concentration (Cmax) of TP and TRE [ Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 3 ]
  • Apparent Total Clearance (CL/F) of TP and TRE [ Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 3 ]
  • 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 ]
  • Time to Maximum Observed Concentration (Tmax) of TP and TRE [ Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 3 ]
  • Apparent Volume of Distribution (Vz/F) of TP and TRE [ Time Frame: Pre-dose and at multiple timepoints post-dose up to Day 3 ]

Central Contacts and Locations

Central contacts

Insmed Medical Information

18444467633medicalinformation@insmed.com

Locations

USA004

Recruiting

Lake Forest, California, United States, 92630

USA003

Recruiting

San Dimas, California, United States, 91773

USA002

Recruiting

Orlando, Florida, United States, 32809

USA001

Recruiting

San Antonio, Texas, United States, 78215

More Information

Sponsor

Insmed Incorporated

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Insmed Incorporated on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.