insomia sleeplessness
Conditions
Interventions
None listed
Sponsors
Actelion Pharmaceuticals
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Signed informed consent prior to any study-mandated procedure. - Male or female aged between 18 and 65 years (inclusive) at screening. - Women of childbearing potential must consistently and correctly practice (from screening, during the entire study, and for at least 1 month after study drug intake) a reliable method of contraception with a failure rate of
Exclusion criteria
Exclusion criteria: - Known hypersensitivity to any excipients of the drug formulations. - Previous treatment with any prescribed or over-the-counter (OTC) medications (including herbal medicines such as St John*s Wort) within 7 days prior to screening except for contraceptives for females. - Treatment with another investigational drug within 3 months prior to screening or having participated in more than 4 investigational drug studies within 1 year prior to screening. - History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening. - History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine. - Excessive caffeine consumption, defined as >= 800 mg per day at screening. - 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 drugs. - Smoking within 3 months prior to screening and inability to refrain from smoking during the course of the study. - Loss of 250 mL or more of blood within 3 months prior to screening. - Positive results from the hepatitis serology, except for vaccinated subjects, at screening. - Positive results from the HIV serology at screening. - Pregnant females as determined by positive urine hCG test at screening or prior to dosing. - Breast-feeding females. - Individuals of Asian descent or other individuals reporting ethanol intolerance (Asian descent defined as: either the individual, or 1 or more parent or grandparent of Asian origin). - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Saccadic eye movements (saccadic reaction time, saccadic peak velocity, and saccadic inaccuracy) to assess sedation; -Smooth pursuit eye movements (percentage of time the eyes of the subjects are in smooth pursuit of the target) to assess attention and eye movement coordination; -Body sway (antero-posterior sway in mm/2min) to assess postural (in)stability; -Adaptive tracking, to assess visuo-motor control and vigilance; -Visual Analog Scales (VAS) according to Bond and Lader to assess mood, alertness, and calmness; -VAS for alcohol intoxication to assess the subjective effects of ethanol; - Visual verbal learning test to test memory; - Almorexant and ethanol pharmacokinetics; and - Safety endpoints (blood pressure, heart rate, electrocardiogram, clinical laboratory tests, (serious) adverse events). | — |
Secondary
| Measure | Time frame |
|---|---|
| - | — |
Countries
Netherlands
Outcome results
None listed