Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

The main objective of this study is to investigate whether repeated administration of a cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of presence in the blood) of ACT-541468

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

Details

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

Criteria

Inclusion Criteria:

• Signed informed consent

• 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

Exclusion Criteria:

• Any contraindication to the study drugs

• History or presence of any disease or 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 drugs

• 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