Comparison of Two Dose Strengths of Selexipag in Healthy Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 21 July 2016
• Main ID: NCT02745860
• Date of registration: 18/04/2016
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: Comparison of Two Dose Strengths of Selexipag in Healthy Adults
• Scientific 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
• Date of first enrolment: June 2016
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02745860
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Margaux Boehler
• Affiliation: Actelion

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy Subjects

Intervention(s)

Drug: Selexipag (pediatric formulation)

Drug: Selexipag (adult formulation)

Primary Outcome(s)

Area under plasma concentration-time curve [AUC(0-inf)] of selexipag and ACT-333679 [Time Frame: From predose until 72 hours postdose for each treatment period]

Maximum plasma concentration (Cmax) of selexipag and ACT-333679 [Time Frame: From predose until 72 hours postdose for each treatment period]

Secondary Outcome(s)

Incidence of safety events of interest [Time Frame: From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)]

Incidence of treatment-emergent adverse events and serious adverse events [Time Frame: From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)]

Time to reach Cmax (tmax) of selexipag and ACT-333679 [Time Frame: From predose until 72 hours postdose for each treatment period]

Area under plasma concentration-time curve [AUC(0-t)] of selexipag and ACT-333679 [Time Frame: From predose until 72 hours postdose for each treatment period]

Terminal half-life (t½) of selexipag and ACT-333679 [Time Frame: From predose until 72 hours postdose for each treatment period]

Secondary ID(s)

AC-065-112

Source(s) of Monetary Support

Please refer to primary and secondary sponsors