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

• Status: Not yet recruiting
• Trial end date: 2022-09-15
• Target enrollment: 0
• Participant gender: Male

Summary

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

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

Details

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

Criteria

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.