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NCT Number: NCT03187678

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

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

i.v. selexipag

Drug

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®.

Other names: ACT-293987

oral selexipag (Uptravi)

Drug

Uptravi is used as an auxiliary medicinal product, as part of the PAH standard treatment and administered according to the local prescribing information

Other names: ACT-293987

Primary outcomes

  1. Number of Participants With at Least One Adverse Event (AE)

    Time frame: 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.

  2. Number of Participants With Prostacyclin-associated Adverse Events

    Time frame: From Day 1 to Day 37

    Prostacyclin-associated AE include headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia.

  3. Number of Participants With Adverse Event Related to Injection Site Reactions

    Time frame: 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.

  4. Number of Participants With Prostacyclin-associated AEs Leading to Study Treatment Discontinuation

    Time frame: 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).

  5. Number of Participants With PAH-related Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2017
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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