A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The main objectives of this phase 1 trial are to evaluate the effect of food on the pharmacokinetics (i.e. how long and how much a compound is present in the blood) of ACT-541468 and to evaluate whether ACT-541468 can affect the pharmacokinetics of midazolam, a CYP3A4 substrate.

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

Details

• Lead Sponsor: Actelion; Idorsia Pharmaceuticals Ltd.
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• Signed informed consent form

• Male subjects aged from 18 to 45 years (inclusive) at screening

• Body mass index (BMI) from 18.0 to 30.0 kg/m2 (inclusive) at screening

• Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests

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

• History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score < 0

• 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