Healthy Subjects Clinical Trial
Official title:
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
Verified date | July 2016 |
Source | Actelion |
Contact | n/a |
Is FDA regulated | No |
Health authority | Czech Republic: State Institute for Drug Control |
Study type | Interventional |
Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Germany | Investigator Site. | Kiel |
Lead Sponsor | Collaborator |
---|---|
Actelion |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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) | Yes |
Secondary | 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) | Yes |
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