Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance

Inclusion Criteria:

• Physically healthy male and female subjects between the ages of 18 and 39
• Typical bedtime between 10pm and 12am; typical wake time between 6am and 8am
• Body Mass Index (BMI) >18 and < 28 kg/m2;

Exclusion Criteria:

• Diagnosis of a sleep disorder within two years of screening or currently
• Sleep Apnea
• A current or lifetime diagnosis of any psychiatric disorder with psychotic features, major depression, bipolar disorder, panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, generalized anxiety disorder, dysthymia, or agoraphobia without panic disorder
• A current diagnosis of alcohol or substance abuse or dependence or a history of alcohol or substance abuse or dependence within the past year
• Subjects who are pregnant, lactating, or planning to become pregnant or subjects who are not willing to use an acceptable form of birth control during the study;
• Lifetime history of brain injury (including concussions, mild traumatic brain injuries, or loss of consciousness for ≥ 10 minutes which resulted in the development of persistent symptoms lasting ≥ 1 month), stroke, brain hemorrhage, seizures (not including infantile febrile seizures), epilepsy, or brain infection caused by meningitis, encephalitis, or any other infectious agent.
• Systemic illness affecting central nervous system (CNS) function;
• Cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, myocardial infarction or family history of sudden cardiac death), hypertension, or hypercholesterolemia;
• Asthma or other reactive airway diseases;
• Hepatic impairment (Child-Pugh A, B, C);
• Any other chronic or unstable medical conditions;
• Current use of statins, ketoconazole, prescription or over-the-counter medications or herbal supplements containing psychoactive properties or stimulants in the judgment of the Investigator-Sponsor or Medical Monitor;
• Treatment with another investigational drug;
• Current daily use of any other medication unless specifically approved by the Principal Investigator;
• Consumption of grapefruit (including grapefruit juice) or treatment with moderate or strong inhibitors of cytochrome P450 3A4 (CYP3A4) within one week prior to randomization;
• Treatment with drugs metabolized by CYP2D6 isoenzyme with a narrow therapeutic index within one week prior to randomization;
• Self-reported regular nicotine use within the past 30 days involving > 4 cigarettes per week or > 2 cigarettes per day;
• Self-reported consumption of alcohol within the past 30 days of >14 standard drinks per week or ≥ 5 standard drinks on any day (men), or > 7 standard drinks per week or ≥ 4 standard drinks on any day (women).
• Use of opioids, benzodiazepines, amphetamines, cocaine, cannabis, or any other illicit drugs within 30 days of screening by self report or a urine toxicology screen;
• Known liver disease or abnormal liver function tests assessed at the time of screening;
• Self-reported regular caffeine use in excess of 200 mg per day on average within six months of screening;
• Habitual long sleepers ( > 9 hours) or short sleepers (< 5 hours);
• Shift work within one month prior to the screening visit or planned shift work during the study;
• Travel of > 3 time zones within one week prior to the screening visit or any other visit;
• Known hypersensitivity or contraindication to any excipients of the drug formulation.