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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Daridorexant 10 mg; Drug: Daridorexant 25 mg

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Idorsia Clinical Trials Information; Phone Number: +1 856 66 13 721; Email: idorsiaclinicaltrials@idorsia.com

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Other Outcome Measures

Outcome Measure	Time Frame
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)
T1/2	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)
Treatment-emergent AEs	From study treatment administration up to End-of-Treatment (EOT) (Total duration: up to 46 days)

Collaborators and Investigators

• Sponsor: Idorsia Pharmaceuticals Ltd.
• Investigators: Study Director: Clinical Trials Study Director, Idosia Pharmaceuticals Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Actual): August 4, 2023
• Study Completion (Actual): August 4, 2023

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ID-078-127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No