Clinical trial NCT03101189: A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects
Official title: A Single-center, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-dose ACT-541468 in Healthy Japanese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: safety
Japanese
pharmacokinetics
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of ACT-541468
timeFrame: From Day1 pre-dose to 48 hours after the last dose on Day 5
measure: Area under the plasma concentration-time curves during a dosing interval [AUC(0-24)] of ACT-541468
timeFrame: From Day1 pre-dose to 48 hours after the last dose on Day 5
Secondary outcomes:
measure: Time to reach Cmax (tmax) of ACT-541468
timeFrame: From Day1 pre-dose to 48 hours after the last dose on Day 5
measure: Terminal half-life [t(1/2)] of ACT-541468
timeFrame: From Day1 pre-dose to 48 hours after the last dose on Day 5
measure: Area under the plasma concentration-time curves from time 0 to 8 h [AUC(0-8)]
timeFrame: From Day1 pre-dose to 48 hours after the last dose on Day 5
measure: Incidence of treatment-emergent adverse events
timeFrame: Up to Day 7 (end of study)
measure: Incidence of adverse events leading to premature discontinuation of study treatment
timeFrame: Up to Day 5
measure: Incidence of any clinical relevant findings in ECG variables
timeFrame: Up to Day 7 (end of study)
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
affiliation: Actelion
name: Clemens Muehlan
role: STUDY_DIRECTOR
References: