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

• Status: Not yet recruiting
• Trial end date: 2022-09-17
• 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 dabigatran and rosuvastatin in healthy male subjects

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

Details

• Lead Sponsor: Idorsia Pharmaceuticals Ltd.
• Treatments: Dabigatran; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.

2. Healthy male subject aged between 18 and 45 years (inclusive) at Screening.

Exclusion Criteria:

1. Known hypersensitivity to daridorexant, rosuvastatin, and/or dabigatran etexilate, or treatments of the same class, or any of its/their excipients.

2. Any history of hemorrhagic disease, whether or not hereditary.

3. Any history of complications with bleeding after surgery or tooth extractions and/or frequent nasal, hemorrhoidal, or gingival bleeding.

4. Activated partial thromboplastin time (aPTT) and/or thrombin time (TT) < 0.8 or > 1.2 at Screening.

5. Clinically relevant findings on the physical examination at Screening.

6. Clinically relevant findings on 12-lead ECG, recorded after 5 min in a supine position at Screening.

7. Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at Screening.