Healthy
Conditions
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
Interventions
Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 10 mg.
Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 25 mg.
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| Treatment-emergent AEs | From study treatment administration up to End-of-Treatment (EOT) (Total duration: up to 46 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) |
| 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) |
Countries
United States
Outcome results
None listed