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
Insmed Incorporated
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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- 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…
Interventions
- DrugTreprostinil Palmitil Inhalation Powder
Oral inhalation using a dry powder inhaler device.
Locations (2)
- Orlando County Research CenterLake Forest, California
- Orange Clinical Research CenterOrlando, Florida