Potential Pharmacokinetic Interaction Between Selexipag and Midazolam in Healthy Male Subjects

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary purpose of this study is to evaluate the effect of repeated doses of selexipag on the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much midazolam is present in the blood)

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

Details

• Lead Sponsor: Actelion
• Treatments: Midazolam; Selexipag

Criteria

Key Inclusion Criteria:

• Signed informed consent form

• Age from 18 to 45 years (inclusive) at screening

• Body mass index (BMI) from 18.0 to 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