A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects

NCT03101189 | Completed Phase 1

• 1 other identifier: AC-078-105
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will bridge results obtained in Caucasian subjects to those in Japanese subjects.

Conditions

Healthy Subjects

Keywords

safety; Japanese; pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration (Cmax) of ACT-541468

  The geometric mean Cmax values will be calculated based on pharmacokinetic (PK) blood sampling

  From Day1 pre-dose to 48 hours after the last dose on Day 5

• Area under the plasma concentration-time curves during a dosing interval [AUC(0-24)] of ACT-541468

  The geometric mean AUC(0-24) values will be calculated based on PK blood sampling

  From Day1 pre-dose to 48 hours after the last dose on Day 5

Secondary Outcomes (6)

• Time to reach Cmax (tmax) of ACT-541468

  From Day1 pre-dose to 48 hours after the last dose on Day 5

• Terminal half-life [t(1/2)] of ACT-541468

  From Day1 pre-dose to 48 hours after the last dose on Day 5

• Area under the plasma concentration-time curves from time 0 to 8 h [AUC(0-8)]

  From Day1 pre-dose to 48 hours after the last dose on Day 5

• Incidence of treatment-emergent adverse events

  Up to Day 7 (end of study)

• Incidence of adverse events leading to premature discontinuation of study treatment

  Up to Day 5

Study Arms (3)

ACT-541468 (25 mg)

EXPERIMENTAL

8 Japanese and 8 Caucasian subjects will receive 25 mg (1 capsule) of ACT-541468 once daily for 5 days

Drug: ACT-541468

ACT-541468 (50 mg)

EXPERIMENTAL

8 Japanese and 8 Caucasian subjects will receive 50 mg (2 capsules) of ACT-541468 once daily for 5 days

Drug: ACT-541468

Placebo

PLACEBO COMPARATOR

2 Japanese / 2 Caucasian subjects will receive 1 placebo capsule to match subjects in the ACT-541468 (25 mg) group and 2 other Japanese / 2 Caucasian subjects will receive 2 placebo capsules to match subjects in the ACT-541468 (50 mg) group

Drug: placebo

Interventions

ACT-541468 DRUG

Capsule

ACT-541468 (25 mg); ACT-541468 (50 mg)

placebo DRUG

Matching placebo capsule

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent form;
• Healthy male and female subjects aged between 20 and 50 years (inclusive) at screening;
• Negative serum pregnancy tests at screening and negative urine pregnancy test at Day 1 for women of childbearing potential and agreement to use a reliable method of contraception for at least 90 days after last study drug intake;
• Body mass index (BMI) of 18.0 to 26.0 kg/m2 (inclusive) at screening;
• Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests;
• Caucasian or Japanese ethnicity.
• Japanese subjects only:
• must be of native Japanese descent (all parents/grandparents of Japanese descent);
• must not have been away from Japan for more than 10 years (at screening visit);
• lifestyle should not have changed significantly since relocation from Japan.

You may not qualify if:

• Any contraindication to the study treatments;
• History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments;
• History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score \< 0;
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Sponsors & Collaborators

• Idorsia Pharmaceuticals Ltd.: lead

Study Sites (1)

Centre for Human Drug Research

Leiden, Netherlands

Location

MeSH Terms

Interventions

daridorexant

Study Officials

• Clemens Muehlan

  Actelion

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 5, 2017
• Study Start: March 15, 2017
• Primary Completion: April 24, 2017
• Study Completion: April 26, 2017
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)