Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: i.v. selexipag; oral selexipag (Uptravi)
Intervention description: Selexipag for intravenous administration, twice daily as an infusion over 87 min. The dose is individualized for each subject to correspond to his/her current oral dose of Uptravi®.; Uptravi is used as an auxiliary medicinal product, as part of the PAH standard treatment and administered according to the local prescribing information
Intervention MeSH terms: Selexipag
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: switch; intravenous; selexipag

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 2.

          -  Subjects currently treated with Uptravi® at a stable dose (i.e. unchanged dose) for at
             least 28 days before Visit 2.

          -  Women of childbearing potential must have a negative pregnancy test at Visit 1
             (screening) and Visit 2.

        Exclusion Criteria:

          -  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
             1.

          -  SBP < 90 mmHg at Visit 1 or at Visit 2.

          -  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.