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

NCT05877222 | Completed Phase 1 FDA Drug

• 1 other identifier: ID-078-127
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

Other Outcomes (5)

• Tmax

  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-inf

  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)

• λz

  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)

Study Arms (2)

Treatment A (5 × 10 mg daridorexant)

EXPERIMENTAL

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

Drug: Daridorexant 10 mg

Treatment B (5 × 25 mg daridorexant)

EXPERIMENTAL

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

Drug: Daridorexant 25 mg

Interventions

Daridorexant 10 mg DRUG

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

Treatment A (5 × 10 mg daridorexant)

Daridorexant 25 mg DRUG

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

Treatment B (5 × 25 mg daridorexant)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

MeSH Terms

Interventions

daridorexant

Study Officials

• Clinical Trials Study Director

  Idosia Pharmaceuticals Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: June 23, 2023
• Primary Completion: August 4, 2023
• Study Completion: August 4, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)