Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: i.v. selexipag; Drug: oral selexipag (Uptravi)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03187678

AC-065A309

2016-004035-21 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Selexipag

Experimental group

Description:

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.

Treatment:

Drug: oral selexipag (Uptravi)

Drug: i.v. selexipag