A single-center, double-blind, placebo-controlled, randomized study to investigate the tolerability, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single- and multiple-dose ACT-541468 in healthy Japanese and Caucasian subjects.
- Conditions
- Sleeping disordersinsomnia
- Registration Number
- NL-OMON45722
- Lead Sponsor
- Actelion Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
- Signed informed consent prior to any study-mandated procedure.
- Healthy male and female subjects aged between 20 and 50 years (inclusive) at screening.
- A woman of childbearing potential must provide:
- Negative serum pregnancy test at screening.
- Negative urine pregnancy test at Day 1.
- Agreement to undertake pregnancy tests up to 30 days after EOT.
- No clinically significant findings on the physical examination at screening.
- Body mass index of 18.0 to 26.0 kg/m2 (inclusive) at screening.
- Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on either arm, after 5 min in the supine position at screening and at Day 1 pre dose.
- 12-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after 5 min in the supine position at screening and at Day 1 pre-dose.
- Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
- Negative results from urine drug screen and alcohol breath test at screening and Day 1.
- Ability to communicate well with the investigator, in the local language (Dutch, English, or Japanese), and to understand and comply with the requirements of the study.
- Subjects must be of Caucasian or Japanese ethnicity.;Japanese subjects only:
- Subjects must be of native Japanese descent (all parents/grandparents of Japanese descent).
* Subjects must not have been away from Japan for more than 10 years (at screening visit).
* Subject's lifestyle should not have changed significantly since relocation from Japan.
- Known hypersensitivity to ACT-541468 or drugs of the same class, or any of the excipients.
- Previous exposure to the study drug.
- Known hypersensitivity or allergy to natural rubber latex.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Previous relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy.
- Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access, or puncture, veins with a tendency to rupture during or after puncture).
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
- Excessive caffeine consumption, defined as > 800 mg per day at screening.
- Nicotine intake (e.g., smoking, nicotine patch, nicotine chewing gum, or electronic cigarettes) within 3 months prior to screening and inability to refrain from nicotine intake from screening until End-of-Study (EOS).
- Treatment with another investigational treatment within 3 months prior to screening or participation in more than 4 investigational treatment studies within 1 year prior to screening.
- Previous treatment with any prescribed medications (including all type of vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John*s Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks or 5 half-lives (whichever is longer) prior to first study treatment administration.
- Loss of 250 mL or more of blood within 3 months prior to screening.
- Positive results from the hepatitis serology, except for vaccinated subjects or subjects with past but resolved hepatitis, at screening.
- Positive results from the HIV serology at screening.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Legal incapacity or limited legal capacity at screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and tolerability: clincal relevant changes in lab, ECG, vital<br /><br>parameters. (S)AE's.<br /><br><br /><br>PK: Cmax, Tmax, T1/2, AUC0-8, AUC0-24, Accumulation index<br /><br><br /><br>PD: change from baseline of pharmacodynamic assessments.</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>