A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants

Study Overview
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Brief Summary
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A Phase 1 trial to investigate bioequivalence between 5 × 10 mg tablets and 2 × 25 mg tablets of daridorexant in healthy male and female Japanese participants

Official Title
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A Single-center, Open-label, Randomized, Crossover Phase 1 Trial to Investigate Bioequivalence Between 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: Daridorexant 10 mg
* Drug: Daridorexant 25 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent in a language understandable to the participant prior to any trial-mandated procedure. Healthy male and female participants aged between 18 and 65 years (inclusive) at Screening. Body mass index of 18.5 to 29.9 kg/m2 (inclusive) at Screening. Participant must be of native Japanese descent (all parents/grandparents of Japanese descent). Participant must not have been away from Japan for more than 10 years (at Screening visit). Participant's lifestyle should not have changed significantly since relocation from Japan. Exclusion Criteria: Known hypersensitivity to daridorexant, or any of its excipients. History of narcolepsy or cataplexy. 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 and clinical chemistry) at Screening. Clinically relevant findings in systolic blood pressure, diastolic blood pressure, and pulse rate, measured on either arm, after 5 min in the supine position at Screening. History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed if performed > 12 weeks prior to administration of first study treatment, cholecystectomy not allowed). Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A (5 × 10 mg daridorexant)<br>Participants will receive a single oral dose of 5 × 10 mg daridorexant. | Drug: Daridorexant 10 mg<br>* Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 10 mg.<br>|
| Experimental: Treatment B (5 × 25 mg daridorexant)<br>Participants will receive a single oral dose of 2 × 25 mg daridorexant. | Drug: Daridorexant 25 mg<br>* Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 25 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | Blood samples for PK analysis will be taken at several timepoints from treatment administration on Day 1 to Day 3 of Study periods 1 and 2 (Total duration: up to 4 days) | 
| AUC0-t |  | Blood samples for PK analysis will be taken at several timepoints from treatment administration on Day 1 to Day 3 of Study periods 1 and 2 (Total duration: up to 4 days) |