Comparison of Two Dose Strengths of Selexipag in Healthy Adults

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Actelion
• Treatments: Selexipag

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