Clinical trial NCT02745860: Comparison of Two Dose Strengths of Selexipag in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: selexipag
pharmacokinetics
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2016-04-20
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Area under plasma concentration-time curve [AUC(0-inf)] of selexipag and ACT-333679
timeFrame: From predose until 72 hours postdose for each treatment period
measure: Maximum plasma concentration (Cmax) of selexipag and ACT-333679
timeFrame: From predose until 72 hours postdose for each treatment period
Secondary outcomes:
measure: Time to reach Cmax (tmax) of selexipag and ACT-333679
timeFrame: From predose until 72 hours postdose for each treatment period
measure: Terminal half-life (t½) of selexipag and ACT-333679
timeFrame: From predose until 72 hours postdose for each treatment period
measure: Area under plasma concentration-time curve [AUC(0-t)] of selexipag and ACT-333679
timeFrame: From predose until 72 hours postdose for each treatment period
measure: Incidence of treatment-emergent adverse events and serious adverse events
timeFrame: From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)
measure: Incidence of safety events of interest
timeFrame: From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)
Other outcomes:
Locations:
Study officials:
affiliation: Actelion
name: Margaux Boehler
References:
citation: 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.