CClinicalTrials.gg
Sign In
CompletedNCT05877222Updated Aug 16, 2023

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 Phase 1 interventional study of Daridorexant 10 mg and Daridorexant 25 mg in Healthy, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-16.

Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Aug 2023, 3 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Idorsia Pharmaceuticals Ltd. is the lead sponsor of 102 studies on the registry; 5 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 9 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Treatment A (5 × 10 mg daridorexant)

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

    Drug: Daridorexant 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

Interventions

  • DrugDaridorexant 10 mg

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

  • DrugDaridorexant 25 mg

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

06

What researchers measure

Primary outcomes

  1. Cmax

    Time frame: 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)

  2. AUC0-t

    Time frame: 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

  1. Tmax

    Time frame: 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)

  2. AUC0-inf

    Time frame: 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)

  3. λz

    Time frame: 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)

  4. T1/2

    Time frame: 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)

  5. Treatment-emergent AEs

    Time frame: From study treatment administration up to End-of-Treatment (EOT) (Total duration: up to 46 days)

07

Study locations

1 site
  • Anaheim Clinical Trials
    Anaheim, California 92801, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05877222
Lead sponsor
Idorsia Pharmaceuticals Ltd.
Responsible party
Sponsor
First posted
May 26, 2023
Start date
Jun 23, 2023
Primary completion
Aug 4, 2023
Completion
Aug 4, 2023
Last update
Aug 16, 2023

Study contacts

Clinical Trials Study Director
study director · Idosia Pharmaceuticals Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Idorsia Pharmaceuticals Ltd.

Start the discussion