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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2022-10-06

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 midazolam and warfarin in healthy male subjects

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

This is a prospective, open-label, fixed-sequence Phase 1 study.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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• A (midazolam & warfarin), B (daridorexant, midazolam, & warfarin), & C (daridorexant & midazolam)

* Treatment A - midazolam and warfarin: In the morning of Day 1, subjects will receive a single oral dose of 2 mg midazolam concomitantly with a single oral dose of 25 mg warfarin under fasted conditions.
* Treatment B - daridorexant, midazolam, and warfarin: Subjects will receive an o.d. oral dose of 50 mg daridorexant in the morning from Day 1 to Day 7 under fasted conditions. In addition, in the morning of Day 1, the oral administration of 50 mg daridorexant will be followed 1 h later by a single oral dose of 2 mg midazolam concomitantly with a single oral dose of 25 mg warfarin under fasted conditions.
* Treatment C - daridorexant and midazolam: In the morning of Day 1, subjects will receive a single oral dose of 50 mg daridorexant followed 1 h later by a single oral dose of 2 mg midazolam under fasted conditions.

Group Type OTHER

Midazolam

Intervention Type DRUG

Subjects will receive a single oral dose of 2 mg midazolam (Treatment A, B, and C).

Warfarin

Intervention Type DRUG

Subjects will receive a single oral dose of 25 mg warfarin (Treatment A and B).

Daridorexant

Intervention Type DRUG

Subjects will receive an o.d. oral dose of 50 mg daridorexant from Day 1 to Day 7 of Treatment B and a single oral dose of 50 mg daridorexant on Day 1 of Treatment C.

Interventions

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Midazolam

Subjects will receive a single oral dose of 2 mg midazolam (Treatment A, B, and C).

Intervention Type DRUG

Warfarin

Subjects will receive a single oral dose of 25 mg warfarin (Treatment A and B).

Intervention Type DRUG

Daridorexant

Subjects will receive an o.d. oral dose of 50 mg daridorexant from Day 1 to Day 7 of Treatment B and a single oral dose of 50 mg daridorexant on Day 1 of Treatment C.

Intervention Type DRUG

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, 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes