Examining the Effects of CXB722 in Neuroendocrine Stress Response in Healthy Males (CXB722-100)

Inclusion Criteria:

• Male, 18 to 34 years of age, inclusive, at screening
• Able to read, understand and converse in English
• Able to read, understand, and provide written, dated informed consent
• Willing to refrain from the use of any concomitant medications (including over-the counter (OTC)) and nutritional/herbal supplements and comply with all study requirements
• Willing to submit to daily breathalyzer testing each day study medication is administered over the course of the study
• In good general health as ascertained by medical history, physical examination (PE) including measurement of vital signs, clinical laboratory evaluations, and 12-lead electrocardiogram (ECG)

Exclusion Criteria:

• Evidence on physical examination or laboratory findings of chronic liver or renal disease or other chronic physical disorders
• Evidence of cardiovascular disease on 12 lead ECG, vital signs or laboratory findings
• Significant anxiety as indicated by a score of 47 or higher on the "Trait" score of Spielberger State-Trait Anxiety Scale
• Family history (first degree relative) of hypertension or cardiovascular disease prior to age 40
• Evidence on physical or laboratory examination of endocrinopathies or immunopathies, including HIV
• BMI of 30 or greater, evidence of significant recent weight change or history of obesity
• History of any psychiatric disorder, or evidence of such a disorder based on a psychiatric evaluation which includes the Structured Clinical Interview for DSM-IV-TR (SCID)
• History of any physical condition which, in the investigator's opinion, might put the participant at risk or interfere with the interpretation of study results
• Use of any prescription or over-the-counter (OTC) medications (including herbal remedies) within 14 days of study randomization
• Use of tobacco products or any nicotine-containing products (e.g., gum, patch) within the past 6 months (prior to screening)
• Positive screening urine test for nicotine or drugs of abuse: cannabinoids, cocaine, amphetamines, barbiturates, opiates, benzodiazepines, or alcohol in the blood
• Unwillingness to agree to avoid strenuous activity over the course of the study
• Poor likelihood, in the investigator's judgment, of full cooperation during the study and/or poor compliance is anticipated
• Previously screened for this trial
• Consumes more than four cups of coffee daily
• Deviates from normal nocturnal sleeping patterns