Clinical trial NCT05877222: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: Cmax
timeFrame: 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)
measure: AUC0-t
timeFrame: 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)
Secondary outcomes:
Other outcomes:
measure: Tmax
timeFrame: 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)
measure: AUC0-inf
timeFrame: 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)
measure: λz
timeFrame: 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)
measure: T1/2
timeFrame: 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)
measure: Treatment-emergent AEs
timeFrame: From study treatment administration up to End-of-Treatment (EOT) (Total duration: up to 46 days)
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
Study officials:
affiliation: Idosia Pharmaceuticals Ltd
name: Clinical Trials Study Director
role: STUDY_DIRECTOR
References: