A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Midazolam and Warfarin in Healthy Male Subjects

A Single-center, Open-label Study to Investigate the Effect of Single- and Multiple-dose Daridorexant on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxymidazolam, and the Effect of Single-dose Daridorexant on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Male Subjects

A study to examine the effect of daridorexant on the way the body absorbs, distributes, and gets rid of midazolam and warfarin in healthy male subjects

Inclusion Criteria:

• Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
• Healthy male subject aged between 18 and 45 years (inclusive) at Screening.

Exclusion Criteria:

• Known hypersensitivity to daridorexant, midazolam, warfarin, or treatments of the same class, or any of their excipients.
• Any history of hemorrhagic disease, whether or not hereditary.
• Any history of complications with bleeding after surgery or tooth extractions and/or frequent nasal, hemorrhoidal, or gingival bleeding.
• Activated partial thromboplastin time (aPTT) > 40 sec and/or international normalized ratio (INR) > 1.15 at Screening.
• Platelet count < 150 or >400 x 10^9/L at Screening.
• Clinically relevant findings on the physical examination at Screening.
• Clinically relevant abnormalities on 12-lead ECG, measured after 5 min in the supine position at Screening.
• Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry) at Screening.