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

Status:	Completed
Conditions:	High Blood Pressure (Hypertension)
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - 75
Updated:	6/3/2018
Start Date:	December 5, 2017
End Date:	May 29, 2018

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

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.

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.

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.

We found this trial at

sites

Universitätsklinikum Giessen und Marburg GmbH, Medizinische Klinik und Poliklinik II, Pneumologie

33 Klinikstraße
Giessen, 35392

Phone: +49 641 99 42 422

from

Giessen,