Comparison of Two Dose Strengths of Selexipag in Healthy Adults

Study Overview
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Brief Summary
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Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.

Detailed Description
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Healthy male adults receive a single dose of selexipag (200 µg) but using a different tablet strength (4 film-coated pediatric tablets of 50 µg versus one film-coated tablet of 200 µg selexipag) during each of the two study periods. There is a washout of 7-9 days between the two study treatment administrations.

Official Title
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Single-center, Open-label, Randomized, Two-way Crossover Study in Healthy Adult Male Subjects to Compare the Pharmacokinetics of Selexipag (ACT-293987) Following Single Oral Administration of 4 Film-coated Pediatric Tablets of 50 µg vs One Film-coated Tablet of 200 µg Selexipag

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Selexipag (adult formulation)
* Drug: Selexipag (pediatric formulation)


Participation Criteria
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Eligibility Criteria
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Key inclusion Criteria: Male subjects aged from 18 to 45 years (inclusive) at screening Signed informed consent form Body mass index (BMI) between 18.0 and 28.0 kg/m2 (inclusive) at screening Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests Key exclusion Criteria: Any contraindication to the study treatments History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence AB<br>Subjects receive 200 µg of selexipag (adult formulation) as a single oral dose during Period 1 and 200 µg of selexipag (pediatric formulation) as a single oral dose during Period 2 | Drug: Selexipag (adult formulation)<br>* One selexipag film-coated tablet of 200 µg<br>* Other names: ACT-293987;Drug: Selexipag (pediatric formulation)<br>* Four selexipag film-coated tablets of 50 µg<br>* Other names: ACT-293987;|
| Experimental: Sequence BA<br>Subjects receive 200 µg of selexipag (pediatric formulation) as a single oral dose during Period 1 and 200 µg of selexipag (adult formulation) as a single oral dose during Period 2 | Drug: Selexipag (adult formulation)<br>* One selexipag film-coated tablet of 200 µg<br>* Other names: ACT-293987;Drug: Selexipag (pediatric formulation)<br>* Four selexipag film-coated tablets of 50 µg<br>* Other names: ACT-293987;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under plasma concentration-time curve [AUC(0-inf)] of selexipag and ACT-333679 | AUC(0-inf) is the area under plasma concentration-time curves for selexipag and its metabolite (ACT-333679), calculated from zero to the extrapolated infinite time | From predose until 72 hours postdose for each treatment period | 
| Maximum plasma concentration (Cmax) of selexipag and ACT-333679 | Cmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679 | From predose until 72 hours postdose for each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach Cmax (tmax) of selexipag and ACT-333679 | tmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679 | From predose until 72 hours postdose for each treatment period | 
| Terminal half-life (t½) of selexipag and ACT-333679 | The period of time required for the concentration levels of selexipag or its metabolite (ACT-333679) to be reduced by one-half | From predose until 72 hours postdose for each treatment period | 
| Area under plasma concentration-time curve [AUC(0-t)] of selexipag and ACT-333679 | AUC(0-t) is the area under plasma concentration-time curves for selexipag and its metabolite (ACT-333679), calculated from zero to time t of the last measured concentration above the limit of quantification | From predose until 72 hours postdose for each treatment period | 
| Incidence of treatment-emergent adverse events and serious adverse events | A treatment-emergent AE is any AE temporally associated with the use of a study treatment, whether or not considered related to the study treatment, including any abnormalities in ECG parameters, vital signs or laboratory tests | From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2) | 
| Incidence of safety events of interest | Events of interest include any abnormalities in ECG, vital signs or laboratory test results | From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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selexipag, pharmacokinetics