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

Avera Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Irritable Bowel Syndrome (IBS)

Treatments

Drug: AV608

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00316550

AV608-107

Details and patient eligibility

About

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

Full 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 with IBS. Female subjects between 18 and 65 years of age who meet diagnostic criteria for Irritable Bowel Syndrome will be eligible for the study.

Eligible subjects will complete a baseline fMRI imaging procedure that includes both emotional visual cues and visceral stimulation. All subjects who participate in the study will receive 3 weeks of treatment with AV608 and 3 weeks of treatment with placebo during the course of the study; the order of the two treatments for each subject will be randomly determined.

Enrollment

24 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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