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

• Status: Terminated
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Irritable Bowel Syndrome.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avera Pharmaceuticals
• Collaborator: University of California, Los Angeles

Criteria

Inclusion Criteria:

• Female, 18 to 65 years of age, inclusive

• Current diagnosis of Irritable Bowel Syndrome (IBS)

• Subjects 50 years of age or older must have had a barium enema and flexible sigmoidoscopy or a colonoscopy and provide a record of this test

• Willing to participate in this study as evidenced by a signed, written informed consent form (ICF)

• If female and of child-bearing potential, willing to avoid pregnancy and practice adequate birth control from the time of study enrollment through at least 30 days after the final dose of study medication

• If female, negative pregnancy test results

• Right handed

• Ambulatory outpatient

• Agrees to refrain from blood donation during the course of the study

• Written and oral fluency in the English language

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