A Multicenter, Open-label, Single-sequence Cross-over Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension Switching From an Oral Stable Dose of Selexipag
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Number of Participants With at Least One Adverse Event (AE)
研究概览
简要总结
The development of selexipag for intravenous administration will be useful to avoid treatment interruptions in patients with pulmonary arterial hypertension (PAH) already treated with selexipag administered orally as tablets (Uptravi®). The target population for intravenous selexipag includes those PAH patients who are hospitalized and are unable to swallow tablets of Uptravi.
The primary objective of this study is to assess whether it is safe for patients with PAH to temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein (intravenous selexipag), and then switching back to the initial oral dose of selexipag.
详细描述
After screening (Visit 1), each subject will participate in the following consecutive treatment periods: Period 1(treatment with oral selexipag at Visit 2/Day 1), Period 2 (treatment with intravenous selexipag at Visit 2/ Day 2 and Day 3), Period 3 (treatment with oral selexipag starting in the evening of Visit 2/Day 3 and ending 7 to 11 days later at Visit 3). Then a safety follow-up period is planned up to end of study visit (EOS), which occurs between Day 33 and Day 40.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form prior to any study-mandated procedure.
- •Male and female subjects aged from 18 to 75 years (inclusive),
- •Subjects with stable pulmonary arterial hypertension (PAH) defined as WHO Functional Class I-III at Visit 1 and Visit 2, and no change (i.e., introduction or dose change) in PAH-specific medication (i.e., ERA, PDE-5 inhibitor or sGC stimulator) and diuretics in the last 28 days prior to Visit
- •Subjects currently treated with Uptravi® at a stable dose (i.e. unchanged dose) for at least 28 days before Visit
- •Women of childbearing potential must have a negative pregnancy test at Visit 1 (screening) and Visit 2.
排除标准
- •Pregnant, planning to become pregnant or lactating.
- •Known and documented moderate or severe hepatic impairment.
- •Subjects having received gemfibrozil at any time since initiation of Uptravi®.
- •Treatment with any prostacyclin and prostacyclin analogs within 28 days prior to Visit
- •SBP < 90 mmHg at Visit 1 or at Visit
- •Known or suspected uncontrolled hyperthyroidism.
- •Severe renal failure and ongoing or planned dialysis.
- •Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results.
- •Known concomitant life-threatening disease with a life expectancy < 12 months.
- •Treatment with another investigational treatment within 3 months of Visit 1.
研究组 & 干预措施
Selexipag
Subjects with stable pulmonary arterial hypertension (PAH) and currently treated with a stable oral dose of Uptravi will be switched to i.v. selexipag from Day 2 to Day 3 (2 infusions on Day 2 and 1 infusion on Day 3). Otherwise, they will continue with their current oral selexipag treatment throughout the study.
干预措施: i.v. selexipag (Drug)
Selexipag
Subjects with stable pulmonary arterial hypertension (PAH) and currently treated with a stable oral dose of Uptravi will be switched to i.v. selexipag from Day 2 to Day 3 (2 infusions on Day 2 and 1 infusion on Day 3). Otherwise, they will continue with their current oral selexipag treatment throughout the study.
干预措施: oral selexipag (Uptravi) (Drug)
结局指标
主要结局
Number of Participants With at Least One Adverse Event (AE)
时间窗: From Day 1 to Day 37
AE is any untoward medical event that occurs in a participant during the course of the study whether or not considered by the investigator as related to the study treatment.
Number of Participants With Prostacyclin-associated Adverse Events
时间窗: From Day 1 to Day 37
Prostacyclin-associated AE include headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia.
Number of Participants With Adverse Event Related to Injection Site Reactions
时间窗: From Day 2 to Day 3
This is the number of participants with at least one clinically significant reaction at the injection site (e.g., erythema/redness, tenderness, swelling, induration, hemorrhage at the injection site) occurring on the days of intravenous (iv) selexipag injection.
Number of Participants With Prostacyclin-associated AEs Leading to Study Treatment Discontinuation
时间窗: From Day 2 to Day 3
This is the number of subjects who discontinued the i.v. selexipag treatment due to prostacyclin-associated adverse events (headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia).
Number of Participants With PAH-related Adverse Events
时间窗: From Day 1 to Day 37
This is the number of participants with at least one AE considered to be related to pulmonary arterial hypertension during the course of the study.
次要结局
未报告次要终点