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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Daridorexant 10 mg; Drug: Daridorexant 25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05877222

ID-078-127

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Treatment A (5 × 10 mg daridorexant)

Experimental group

Description:

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

Treatment:

Drug: Daridorexant 10 mg

Treatment B (5 × 25 mg daridorexant)

Experimental group

Description:

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

Treatment:

Drug: Daridorexant 25 mg