A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects
- Registration Number
- NCT03101189
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo 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 ACT-541468 (25 mg) ACT-541468 8 Japanese and 8 Caucasian subjects will receive 25 mg (1 capsule) of ACT-541468 once daily for 5 days ACT-541468 (50 mg) ACT-541468 8 Japanese and 8 Caucasian subjects will receive 50 mg (2 capsules) of ACT-541468 once daily for 5 days
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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
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
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
Trial Locations
- Locations (1)
Centre for Human Drug Research
🇳🇱Leiden, Netherlands