Healthy Subjects
Conditions
Keywords
safety, Japanese, pharmacokinetics
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.
Interventions
DRUGACT-541468
Capsule
DRUGplacebo
Matching placebo capsule
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) of ACT-541468 | From Day1 pre-dose to 48 hours after the last dose on Day 5 | The geometric mean Cmax values will be calculated based on pharmacokinetic (PK) blood sampling |
| Area under the plasma concentration-time curves during a dosing interval [AUC(0-24)] of ACT-541468 | From Day1 pre-dose to 48 hours after the last dose on Day 5 | The geometric mean AUC(0-24) values will be calculated based on PK blood sampling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Terminal half-life [t(1/2)] of ACT-541468 | From Day1 pre-dose to 48 hours after the last dose on Day 5 | The geometric mean t(1/2) values will be calculated based on PK blood sampling |
| 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 | The geometric mean AUC(0-8) values will be calculated based on PK blood sampling |
| Incidence of treatment-emergent adverse events | Up to Day 7 (end of study) | The percentage of subjects with treatment-emergent adverse events will be reported |
| Incidence of any clinical relevant findings in ECG variables | Up to Day 7 (end of study) | The number of subjects with any treatment-emergent electrocardiogram (ECG) abnormalities will be reported |
| Incidence of adverse events leading to premature discontinuation of study treatment | Up to Day 5 | The number of subjects who prematurely discontinued the study treatment due to an adverse event will be reported |
| Time to reach Cmax (tmax) of ACT-541468 | From Day1 pre-dose to 48 hours after the last dose on Day 5 | The median tmax values will be calculated based on PK blood sampling |
Countries
Netherlands
Outcome results
None listed