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

NCT ID: NCT05877222

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-23
• Study Completion Date: 2023-08-04

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment A (5 × 10 mg daridorexant)

Participants will receive a single oral dose of 5 × 10 mg daridorexant.

Group Type: EXPERIMENTAL

Daridorexant 10 mg

Intervention Type: DRUG

Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 10 mg.

Treatment B (5 × 25 mg daridorexant)

Participants will receive a single oral dose of 2 × 25 mg daridorexant.

Group Type: EXPERIMENTAL

Daridorexant 25 mg

Intervention Type: DRUG

Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 25 mg.

Interventions

Daridorexant 10 mg

Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 10 mg.

Intervention Type: DRUG

Daridorexant 25 mg

Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 25 mg.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials Study Director

Role: STUDY_DIRECTOR

Idosia Pharmaceuticals Ltd

Locations

Anaheim Clinical Trials

Anaheim, California, United States

Countries

United States

Other Identifiers

ID-078-127

Identifier Type: -

Identifier Source: org_study_id