Efficacy and Safety Study of Adipiplon, Placebo and an Active Control in Primary Insomniacs

Exclusion Criteria

• •Clinically significant unstable medical illness;
• •Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease;
• •History of cancer other than basal cell carcinoma, squamous cell carcinoma of the skin or cancer in situ within 5 years of screening;
• •Supine or sitting blood pressure \> 140/90 mmHg at the screening or baseline visits;
• •Heart rate \>100 bpm at the screening or baseline visits;
• •Within the past three years, clinically significant psychiatric illness, including chronic psychiatric illness or any Axis I condition;
• •History or presence of chronic pain;
• •History of epilepsy or serious head injury;
• •Other than primary insomnia, a history of clinically significant sleep disorder including narcolepsy, parasomnia as an adult, circadian rhythm disorder, restless leg syndrome, or on the initial baseline PSG, sleep apnea \[Apnea Hypopnea Index (AHI) \>10\] or Periodic Limb Movement Disorder \[Periodic Limb Movement Arousal Index (PLMAI) \> 10\];
• •Any condition that may affect drug absorption;
• •Smokers who habitually smoke more than 10 cigarettes per day or smoke during the overnight hours;
• •Travel across more than three time zones, an expected change in sleep schedules of 3 hours or more, or involvement in rotating shift work within 14 days prior to screening or during the study period;
• •Self-report of napping ≥30 minutes more than 2 times per week within the last month;
• •Any clinically significant abnormal finding on physical examination, vital signs, ECG, or clinical laboratory tests, as determined by the investigator. (The QTc interval must be ≤430 msec. for males and ≤450 msec for females);
• •Known or suspected diagnosis of Acquired Immune Deficiency Syndrome, or previous or current positive result on human immunodeficiency virus antibody or antigen testing;
• •History or laboratory finding of positive hepatitis B surface antigen or hepatitis C core antibody;
• •History of allergies, or known sensitivity, hypersensitivity, or adverse reaction to any drug similar to adipiplon, including benzodiazepines, or zolpidem, zaleplon, zopiclone, or eszopiclone;
• •Use of any psychotropic medications, including over-the-counter (OTC) and herbal products, that may affect sleep/wake function within one week or five half-lives (whichever is longer) prior to screening or need to use any of these medications at any time during the study;
• •Pregnant or lactating females;
• •Positive serum pregnancy test at screening or urine pregnancy test at baseline;
• •Recent history (≤ one year) of alcohol or drug abuse, or current evidence of substance dependence or abuse as defined by DSM-IV criteria;
• •Regular consumption of large amounts of xanthine-containing substances (i.e. more than 5 cups of coffee or equivalent amounts of xanthine-containing substances per day);
• •Have eaten grapefruit or had grapefruit juice from baseline through the completion of study dosing;
• •Self report of a usual consumption of more than 14 units of alcohol per week;
• •Requiring the concomitant usage of any 3A4 inhibitors;
• •Any prior exposure to adipiplon (formerly known as NG2-73).