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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: ACT-541468; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03101189

AC-078-105

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 3 patient groups, including a placebo group

ACT-541468 (25 mg)

Experimental group

Description:

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

Treatment:

Drug: ACT-541468

ACT-541468 (50 mg)

Experimental group

Description:

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

Treatment:

Drug: ACT-541468

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo