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 1

Completed

• Conditions: Healthy
• Interventions: Drug: Dabigatran etexilate; Drug: Rosuvastatin; Drug: Daridorexant

• Registration Number: NCT05480475
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-27
• Study First Posted: 2022-07-29
• Study Start: 2022-09-03
• Primary Completion: 2022-09-17
• Study Completion: 2022-09-17
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Study treatment (Period 1, 2, and 3)	Dabigatran etexilate	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
Study treatment (Period 1, 2, and 3)	Rosuvastatin	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
Study treatment (Period 1, 2, and 3)	Daridorexant	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

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

CEPHA s.r.o.; 🇨🇿 Pilsen, Czechia