| Study Summary: |
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Up to 216 healthy volunteers will be enrolled to participate in the 10 day study. After
screening procedures have been completed (at SFVAMC), Days 1 - 7 will take place in
subjects' homes, where their sleep/wake activity will be monitored. Days 8 - 10 will take
place at Moffitt Hospital. On Day 10, subjects will take one dose of either almorexant
100mg, almorexant 200mg, zolpidem 10mg, or placebo. Cognitive tests will be administered to
subjects throughout Day 10. Subjects will return for follow-up safety labs within 5 - 12
days of dosing with study medication. Based on animal studies, it is anticipated that
subjects who take almorexant will be less cognitively impaired than those who take zolpidem.
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| Criteria: |
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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.
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