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Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence AB | Experimental | 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 |
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| Sequence BA | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selexipag (adult formulation) | Drug | One selexipag film-coated tablet of 200 µg |
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| 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 |
| 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 |
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Key inclusion Criteria:
Key exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaux Boehler | Actelion |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28639216 | Derived | Boehler M, Bruderer S, Ulc I, Dingemanse J. Biocomparison Study of Adult and Paediatric Dose Strengths of the Prostacyclin Receptor Agonist Selexipag. Eur J Drug Metab Pharmacokinet. 2018 Feb;43(1):115-120. doi: 10.1007/s13318-017-0424-z. |
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| ID | Term |
|---|---|
| C523468 | selexipag |
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| Selexipag (pediatric formulation) | Drug | Four selexipag film-coated tablets of 50 µg |
|
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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) |