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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05877222
• Other study ID #: ID-078-127
• Status: Completed
• Phase: Phase 1
• Start date: June 23, 2023
• Est. completion date: August 4, 2023

Study information

• Verified date: August 2023
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 4, 2023
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Daridorexant 10 mg
Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 10 mg.
• Daridorexant 25 mg
Daridorexant will be available as film-coated tablets for oral administration formulated at strengths of 25 mg.

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	?z		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	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)
Other	Treatment-emergent AEs		From study treatment administration up to End-of-Treatment (EOT) (Total duration: up to 46 days)
Primary	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)
Primary	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)