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

Study Overview
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Brief Summary
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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

Official Title
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A Single-center, Open-label, Three-period, Fixed-sequence Design Study to Investigate the Effect of Daridorexant on the Pharmacokinetics of Dabigatran and Rosuvastatin in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Dabigatran etexilate
* Drug: Rosuvastatin
* Drug: Daridorexant


Participation Criteria
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Eligibility Criteria
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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, rosuvastatin, and/or dabigatran etexilate, or treatments of the same class, or any of its/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) and/or thrombin time (TT) < 0.8 or > 1.2 at Screening. Clinically relevant findings on the physical examination at Screening. Clinically relevant findings on 12-lead ECG, recorded after 5 min in a supine position at Screening. Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at Screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Interventional Model Description: Three-period, fixed-sequence design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study treatment (Period 1, 2, and 3)<br>Period 1: Treatment A1 - dabigatran etexilate; Treatment A2 - rosuvastatin Period 2: Treatment B - daridorexant Period 3: Treatment C1 - dabigatran etexilate and daridorexant; Treatment C2 - rosuvastatin and daridorexant | Drug: Dabigatran etexilate<br>* On Day 1 (Treatment A1) and on Day 9 (Treatment C1) a single oral dose of 75 mg dabigatran etexilate will be administered under fasted conditions.<br>Drug: Rosuvastatin<br>* On Day 3 (Treatment A2) and on Day 11 (Treatment C2) a single oral dose of 10 mg rosuvastatin will be administered under fasted conditions.<br>Drug: Daridorexant<br>* On Day 7 and Day 8 (Treatment B), on Day 9 and Day 10 (Treatment C1), and on Day 11 through 14 (Treatment C2) subjects will receive 50 mg daridorexant o.d. under fasted conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of dabigatran |  | Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days). | 
| Cmax of rosuvastatin |  | Blood samples for pharmacokinetic analyses will be taken at various time points from Day 1 to 7 and Day 9 to 15 (total duration: 14 days). |