A Phase 1, Randomized, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, And Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Parts A and B: Number of Participants who Experienced an Adverse Event (AE)
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and tolerability of single and multiple doses of treprostinil palmitil inhalation powder in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participant is considered by the investigator to be in good general health as determined by medical history, physical examination findings, vital sign measurements, 12-lead electrocardiogram (ECG) results, and clinical laboratory test results within normal limits or considered not clinically significant by the investigator, at screening.
排除标准
- •The participant has an allergy, documented hypersensitivity, or contraindication to the ingredients or to any of the excipients of treprostinil palmitil inhalation powder or treprostinil.
- •The participant has used any prescription (excluding hormonal birth control) or over-the-counter medications, including herbal or nutritional supplements, within 14 days before the first dose of study drug and throughout the study.
- •The participant has a history of anaphylaxis, previously documented hypersensitivity reaction to any drug.
- •The participant has had a surgical procedure that required general anesthesia (or equivalent) within 90 days prior to screening.
- •The participant has a body mass index <19.0 or >32.0 kilograms per square meter (kg/m^2) at screening.
- •The participant has a history of syncope not due to dehydration or vasovagal syncope (eg, congenital cardiac arrhythmias such as Wolff-Parkinson-White syndrome, nodal tachycardia, ventricular tachycardia, etc).
- •The participant has active liver disease or hepatic dysfunction at screening or check-in visits.
- •The participant has a history of human immunodeficiency virus (HIV) infection.
- •The participant has a history of abnormal bleeding or bruising.
- •The participant has a history of malignancy in the past 5 years, with exception of nonmelanoma skin cancer.
- •The participant has a current history (within the past 12 months) of substance and/or alcohol abuse.
- •The participant is a current user of cigarettes (average of ≥1 cigarette/day) or e-cigarettes within 30 days prior to screening.
- •The participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug or throughout the study.
- •Note: Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
Part A (SAD Cohort 1): TPIP
Participants in the single ascending dose (SAD) Cohort 1 received a single dose of TPIP at Dose A, Dose B, or Dose C by oral inhalation on Day 1.
干预措施: Treprostinil Palmitil Inhalation Powder (Drug)
Part A (SAD Cohort 2): TPIP or Placebo
Participants in SAD Cohort 2 received a single dose of TPIP at Dose D or matching placebo by oral inhalation on Day 1.
干预措施: Treprostinil Palmitil Inhalation Powder (Drug)
Part A (SAD Cohort 2): TPIP or Placebo
Participants in SAD Cohort 2 received a single dose of TPIP at Dose D or matching placebo by oral inhalation on Day 1.
干预措施: Placebo (Drug)
Part B (MAD Cohort 2): TPIP or Placebo
Participants in MAD Cohort 2 received TPIP up to Dose D or matching placebo, QD by oral inhalation on Days 1 through 7.
干预措施: Treprostinil Palmitil Inhalation Powder (Drug)
Part A (SAD Cohort 3): TPIP or Placebo
Participants in SAD Cohort 3 received a single dose of TPIP at Dose E or matching placebo by oral inhalation on Day 1.
干预措施: Treprostinil Palmitil Inhalation Powder (Drug)
Part A (SAD Cohort 3): TPIP or Placebo
Participants in SAD Cohort 3 received a single dose of TPIP at Dose E or matching placebo by oral inhalation on Day 1.
干预措施: Placebo (Drug)
Part B (MAD Cohort 1): TPIP or Placebo
Participants in the multiple ascending dose (MAD) Cohort 1 received TPIP at Dose B, Dose C or matching placebo, once daily (QD) by oral inhalation on Days 1 through 7.
干预措施: Treprostinil Palmitil Inhalation Powder (Drug)
Part B (MAD Cohort 1): TPIP or Placebo
Participants in the multiple ascending dose (MAD) Cohort 1 received TPIP at Dose B, Dose C or matching placebo, once daily (QD) by oral inhalation on Days 1 through 7.
干预措施: Placebo (Drug)
Part B (MAD Cohort 2): TPIP or Placebo
Participants in MAD Cohort 2 received TPIP up to Dose D or matching placebo, QD by oral inhalation on Days 1 through 7.
干预措施: Placebo (Drug)
结局指标
主要结局
Parts A and B: Number of Participants who Experienced an Adverse Event (AE)
时间窗: Up to Day 31 in Part A and Day 37 in Part B
Safety and tolerability of single and multiple doses of treprostinil inhalation powder will be determined in healthy participants.
次要结局
- Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil Palmitil(Part A: Predose and at multiple time points postdose up to Day 4; Part B: Predose and at multiple time points postdose up to Day 10)
- Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil(Part A: Predose and at multiple time points postdose up to Day 4; Part B: Predose and at multiple time points postdose up to Day 10)