Status:
TERMINATED
Pilot Study to Assess the Effects of AV608 on Irritable Bowel Syndrome
Lead Sponsor:
Avera Pharmaceuticals
Collaborating Sponsors:
University of California, Los Angeles
Conditions:
Irritable Bowel Syndrome (IBS)
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief 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.
Detailed Description
This is a single-center, randomized, double-blind, placebo-controlled, cross-over study to assess the effects of AV608 on brain processing of visceral stimuli and emotional visual cues in subjects wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00316550
Start Date
April 1 2006
End Date
September 1 2007
Last Update
February 25 2008
Active Locations (1)
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1
UCLA Center for Neurovisceral Sciences and Women's Health
Los Angeles, California, United States, 90095