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

NCT ID: NCT03101189

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2017-04-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

ACT-541468 (25 mg)

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

Group Type: EXPERIMENTAL

ACT-541468

Intervention Type: DRUG

Capsule

ACT-541468 (50 mg)

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

Group Type: EXPERIMENTAL

ACT-541468

Intervention Type: DRUG

Capsule

Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Matching placebo capsule

Interventions

ACT-541468

Capsule

Intervention Type: DRUG

placebo

Matching placebo capsule

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clemens Muehlan

Role: STUDY_DIRECTOR

Actelion

Locations

Centre for Human Drug Research

Leiden, , Netherlands

Countries

Netherlands

Other Identifiers

AC-078-105

Identifier Type: -

Identifier Source: org_study_id