NCT07643155招募中1 期
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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 6
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Group 4: Treprostinil Palmitil Inhalation Powder
Experimental
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.
干预措施: Treprostinil Palmitil Inhalation Powder (Drug)
Group 3: Treprostinil Palmitil Inhalation Powder
Experimental
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.
干预措施: Treprostinil Palmitil Inhalation Powder (Drug)
Group 2: Treprostinil Palmitil Inhalation Powder
Experimental
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.
干预措施: Treprostinil Palmitil Inhalation Powder (Drug)
Group 1: Treprostinil Palmitil Inhalation Powder
Experimental
Healthy participants with normal hepatic function will receive a single dose of TPIP on Day 1.
干预措施: Treprostinil Palmitil Inhalation Powder (Drug)
研究者
研究点 (6)
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