A study to evaluate whether it is safe for patients with pulmonary arterial hypertension to temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein (intravenous selexipag)

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2016-004035-21-DE
• Date of registration: 14/02/2017
• Prospective Registration: Yes
• Primary sponsor: Actelion Pharmaceuticals Ltd
• Public title: A study to evaluate whether it is safe for patients with pulmonary arterial hypertension to temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein (intravenous selexipag)
• Scientific 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
• Date of first enrolment: 23/05/2017
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004035-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: Double blind: Parallel group: Cross over: Other: yes; Other trial design description: Single-sequence 3-period crossover design; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Germany, United States

Contacts

• Name: Clinical Trial Disclosure Desk
• Affiliation: Actelion Pharmaceuticals Ltd

• Name: Clinical Trial Disclosure Desk
• Affiliation: Actelion Pharmaceuticals Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
1. Signed informed consent prior to any study-mandated procedure.
2. Male and female subjects at least 18 to 75 years inclusive.
3. Subjects with PAH belonging to the Updated Clinical Classification Group 1
4. Subjects who have been prescribed Uptravi® in compliance with local prescribing information (i.e., SmPC or USPI).
5. Stable PAH defined as WHO Functional Class (FC) 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.
6. Subjects currently treated with Uptravi® at a stable dose (i.e. unchanged dose) for at least 28 days before Visit 2.
7. A woman of childbearing potential is eligible only if she has a negative urine pregnancy test at Visit 1 and at Visit 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion criteria:
1. Pregnant, planning to become pregnant or lactating.
2. Known and documented moderate or severe hepatic impairment.
3. Subjects having received gemfibrozil at any time since initiation of Uptravi®.
4. Treatment with any prostacyclin and prostacyclin analogs within 28 days prior to Visit 1.
5. SBP < 90 mmHg at Visit 1 or at Visit 2.
6. Known or suspected uncontrolled hyperthyroidism.
7. Severe renal failure and ongoing or planned dialysis.
8. Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease. This
includes subjects for whom participation in the study might be associated with excessive stress, in the opinion of the investigator.
9. Known concomitant life-threatening disease with a life expectancy < 12 months.
10. Treatment with another investigational treatment within 3 months of Visit 1.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Pulmonary arterial hypertension
MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Intervention(s)

Product Name: Selexipag
Product Code: ACT-293987
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Selexipag
Current Sponsor code: ACT-293987
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 1800-

Primary Outcome(s)

Main Objective: The primary objective of this study is to assess whether temporary switching from a stable oral dose of selexipag to an intravenous (i.v.) dose of selexipag providing comparable exposure to active metabolite ACT-333679 and switching back to the initial oral dose of selexipag is safe and well tolerated in subjects with stable pulmonary arterial hypertension (PAH).

Timepoint(s) of evaluation of this end point: Over Period 1, Period 2 and Period 3 combined

Primary end point(s): Main safety variables are:
- Proportion of discontinuations due to prostacyclin-associated adverse
events (AEs)
- Proportion of AEs and serious AEs
- Proportion of prostacyclin-associated AEs
- Proportion of AEs related to injection site reactions
- Proportion of PAH-related AEs

Secondary Objective: NA

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: NA

Secondary end point(s): NA

Secondary ID(s)

AC-065A309

Source(s) of Monetary Support

Actelion Pharmaceuticals Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 03/05/2019
• Date Completed: 29/05/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-004035-21/results