Pilot Study to Assess the Effects of AV608 on Irritable Bowel Syndrome

Exclusion Criteria

• •Evidence of structural abnormality of the gastrointestinal tract or GI diseases/conditions
• •Current evidence or diagnosis of peptic ulcer
• •Endoscopic bowel evaluation with evidence of cancer, inflammatory bowel disease, or other structural disease
• •History of abdominal surgery such as adhesion lysis or any gastrointestinal surgery
• •History of gastroesophageal reflux disease not controlled by a stable dose of medication
• •Any evidence of or treatment of malignancy within the previous 5 years
• •Clinical evidence of any disease that may interfere with participation in the study
• •Existence of surgical or medical conditions which interfere with the absorption, distribution, metabolism and excretion of the study drug
• •Symptoms of a significant clinical illness within the 2 weeks prior to Screening
• •Type 1 diabetes mellitus, insulin-dependent Type 2 diabetes mellitus, and thyroid disorders or other endocrine disorders that are not well controlled by appropriate therapy
• •A QTc interval of greater than or equal to 450 msec at Screening
• •Presence of a psychotic disorder, bipolar disorder, alcohol or substance dependence (other than nicotine dependence) or eating disorder within the previous year according to DSM-IV-TR criteria
• •Seizure disorder
• •Subjects who have previously participated in a clinical trial for AV608 (previously known as NKP608 and CGP608)
• •Positive drug test result at Screening
• •Use of investigational drugs, products or devices within 30 days prior to Screening
• •Planned use of certain drugs during the study that affect the central nervous system, gastrointestinal motility, autonomic activity or pain sensation
• •Use of pimozide, terfenadine, astemizole, or cisapride during the study
• •Presence of moderate or severe allergy
• •Regular intake of more than 2 units of alcohol per day
• •Pregnant or breast feeding
• •Subjects with morbid obesity
• •Subjects with metal implants or large tattoo
• •Any clinically significant abnormalities on the Screening physical examination, ECG or laboratory tests
• •Members of the investigative staff or their immediate family members
• •Any other condition that the investigator believes would jeopardize the safety or rights of the subject or would render the subject unable to comply with the study protocol
• •Regular use of more than 10 cigarettes per day