Healthy Subjects
Conditions
Keywords
selexipag, pharmacokinetics
Brief summary
Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.
Detailed description
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.
Interventions
DRUGSelexipag (adult formulation)
One selexipag film-coated tablet of 200 µg
DRUGSelexipag (pediatric formulation)
Four selexipag film-coated tablets of 50 µg
Sponsors
Actelion
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under plasma concentration-time curve [AUC(0-inf)] of selexipag and ACT-333679 | From predose until 72 hours postdose for each treatment period | 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 |
| Maximum plasma concentration (Cmax) of selexipag and ACT-333679 | From predose until 72 hours postdose for each treatment period | Cmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under plasma concentration-time curve [AUC(0-t)] of selexipag and ACT-333679 | From predose until 72 hours postdose for each treatment period | 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 |
| Time to reach Cmax (tmax) of selexipag and ACT-333679 | From predose until 72 hours postdose for each treatment period | tmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679 |
| Incidence of safety events of interest | From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2) | Events of interest include any abnormalities in ECG, vital signs or laboratory test results |
| Incidence of treatment-emergent adverse events and serious adverse events | From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2) | 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 |
| Terminal half-life (t½) of selexipag and ACT-333679 | From predose until 72 hours postdose for each treatment period | The period of time required for the concentration levels of selexipag or its metabolite (ACT-333679) to be reduced by one-half |
Outcome results
None listed