Study On The Effect Of GW876008 On Cerebral Blood Flow In Irritable Bowel Syndrome (IBS) Patients And Healthy Volunteers

Study Overview
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Brief Summary
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This is a three-period crossover study to compare GW876008 and placebo to see if GW876008 will normalise blood flow responses after different emotional stimuli.

Official Title
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A Phase IIa Experimental Medicine Study Assessing Alterations in Regional Cerebral Blood Flow by Functional Magnetic Resonance Imaging (fMRI) in Female IBS Patients and Healthy Controls Following Single Doses of GW876008, a Corticotrophin Releasing Factor 1 Receptor Antagonist (CRF1-RA)

Conditions
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Irritable Colon, Irritable Bowel Syndrome (IBS)

Intervention / Treatment
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* Drug: GW876008 200mcg
* Drug: GW876008 20mcg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject should not have been taking and medication for the treatment of IBS for 1 month prior to the study Negative serum pregnancy tests (serum a-HCG negative) at Screening (Visit 1), and negative urine pregnancy tests at Visits 1, 2, 3 prior to study medication dose. Non-tobacco user (abstinence from tobacco use for at least 1 month before the start of the study). Normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ECG at screen). Exclusion Criteria: Subjects who are pregnant or nursing. Current evidence, or history of (at any time in the past) of a biochemical or structural abnormality of the digestive tract. including (but not limited to): inflammatory bowel disease (Crohn's disease or ulcerative colitis); functional dyspepsia; lactose intolerance, not on a stable diet; Celiac Disease Subjects who are taking NSAIDs on a regular basis or within 48 hours of a study day. The subject has a positive pre-study urine drug/alcohol screen. A positive pre-study HIV 1 / 2, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of the start of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GW876008 20mcg<br>GW876008 20mcg | Drug: GW876008 20mcg<br>* GW876008 20mcg<br>|
| Experimental: GW876008 200mcg<br>GW876008 200mcg | Drug: GW876008 200mcg<br>* GW876008<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal reductions in the amygdala during viewing of emotional faces and during abdominal pain threat as measured by the fMRI. |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaires to assess IBS symptoms and anxiety |  | throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS fMRI