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

NCT00316550 | Terminated Phase 1

• 1 other identifier: AV608-107
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Irritable Bowel Syndrome (IBS)

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the effect of AV608 on regional brain responses as measured by fMRI during conditioned and unconditioned visceral pain due to rectal distension.

Secondary Outcomes (1)

• The effect of AV608 on regional brain responses to emotional visceral cues as measured by fMRI and the visceral pain threshold during rectal distension will be evaluated as secondary efficacy endpoints.

Interventions

AV608 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avera Pharmaceuticals: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

UCLA Center for Neurovisceral Sciences and Women's Health

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Joao Siffert, MD

  Avera Pharmaceuticals, Inc.

  STUDY DIRECTOR

• Kirsten Tillisch, MD

  UCLA Center for Neurovisceral Sciences and Women's Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 19, 2006
• First Posted: April 21, 2006
• Study Start: April 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: September 1, 2007
• Last Updated: February 25, 2008

Record last verified: 2008-02

Locations

US (1)