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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: Treprostinil Palmitil Inhalation Powder 		Healthy participants with normal hepatic function will receive a single dose of TPIP on Day 1.
  • Drug: Treprostinil Palmitil Inhalation Powder
    Oral inhalation using a dry powder inhaler device.
    Other names:
    • INS1009
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.
  • Drug: Treprostinil Palmitil Inhalation Powder
    Oral inhalation using a dry powder inhaler device.
    Other names:
    • INS1009
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.
  • Drug: Treprostinil Palmitil Inhalation Powder
    Oral inhalation using a dry powder inhaler device.
    Other names:
    • INS1009
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.
  • Drug: Treprostinil Palmitil Inhalation Powder
    Oral inhalation using a dry powder inhaler device.
    Other names:
    • INS1009

Recruiting Locations

Orlando County Research Center
Lake Forest, California 92630

Orange Clinical Research Center
Orlando, Florida 32809

More Details

Status
Recruiting
Sponsor
Insmed Incorporated

Study Contact

Insmed Medical Information
18444467633
medicalinformation@insmed.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.