[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643595":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":34,"centralContacts":38,"locations":43,"responsibleParty":45,"collaborators":43,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":43,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":43,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":43,"overallStatus":67,"whyStopped":43,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":43},{"fullName":5,"class":6},"Insmed Incorporated","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Treprostinil Palmitil Inhalation Powder","EXPERIMENTAL","Healthy participants with normal hepatic function will receive a single dose of TPIP on Day 1.",[13],"Drug: Treprostinil Palmitil Inhalation Powder",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"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.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"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.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Treprostinil Palmitil Inhalation Powder","Oral inhalation using a dry powder inhaler device.",[9,15,19,23],[33],"INS1009",[35],{"name":36,"affiliation":5,"role":37},"Study Director","STUDY_DIRECTOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Insmed Medical Information","CONTACT","18444467633",null,"medicalinformation@insmed.com",{"type":46,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100643595","phase-1-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-100643595",false,"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","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","Inclusion Criteria:\n\n* Body mass index between 18.0 and 40.0 kilograms per square meter (kg\u002Fm\\^2), inclusive.\n\nInclusion Criteria for Participants with Normal Hepatic Function\n\n* 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).\n\nInclusion Criteria for Participants With Hepatic Impairment:\n\n* Diagnosis of chronic (\\>6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history.\n* Participants with type 2 diabetes mellitus may be included, if they have:\n\n  * glycosylated hemoglobin A1C ≤8.5% at screening\n  * fasting blood glucose ≤240 milligrams per deciliter (mg\u002FdL), while participant is using their normal diabetes medication, at screening and check-in.\n\nExclusion Criteria:\n\n* History of stomach or intestinal surgery or resection that would potentially alter absorption and\u002For excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair are allowed).\n* Use or intend to use any moderate or strong inducers or inhibitors of CYP2C8 or CYP2C9 within 30 days prior to dosing.\n* 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.\n\nExclusion Criteria for Participants with Normal Hepatic Function\n\n* 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).\n* Positive hepatitis panel and\u002For positive human immunodeficiency virus test. Participants whose results are compatible with prior immunization may be included.\n* 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.\n\nExclusion Criteria for Participants With Hepatic Impairment:\n\n* Current organ transplant or waiting for organ transplant scheduled to occur during the trial.\n* Hospitalization for hepatic encephalopathy within 3 months prior to dosing.\n* Encephalopathy ≥Grade 2.\n* History of drug\u002Fchemical abuse within 1 year prior to check-in. Marijuana use is not exclusionary.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",true,"ALL","18 Years","70 Years",{"count":59,"type":60},30,"ESTIMATED","INTERVENTIONAL",[63],"PHASE1","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.",[66],"Hepatic Impairment","NOT_YET_RECRUITING","2026-06-08",{"date":70,"type":71},"2026-06-11","ACTUAL",{"date":73,"type":60},"2026-06-10",{"date":75,"type":60},"2027-02-07",{"name":5,"class":6}]