IRB Number:

07-004093

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

This study is being done to look at the effects (good and bad) of AT-1001 will have on you and your celiac disease. AT-1001 is being studied as a possible drug used to treat celiac disease. You will be challenged with gluten during this study.

Who is Eligible to Participate in the Study?

You must have biopsy-proven celiac disease and need to have been on a gluten free diet for at least 6 months.

Minimum Age:

18

Maximum Age:

72

What is Involved With this Study?

Subjects will be assigned randomly (as in a flip of a coin) to one of four study arms. The study arms are:

1. AT-1001 capsules (1mg) with gluten challenge


2. AT-1001 capsules (4mg) with gluten challenge


3. AT-1001 capsules (8mg) with gluten challenge


4. Drug placebo (inactive substance) with gluten challenge

The visits may include the following: physical examination by study physician, blood drawn, overnight urine collection and electrocardiogram.

How long will the Study run?

You will be in this study for 9-10 weeks with seven visits to the Mayo Clinic.

Who can I Contact for Additional Information on this Trial?

Please contact Carol Van Dyke, at 507-266-7842 during the hours of 7:30 am to 3:00 pm, M-F Mayo Clinic Rochester.

What is/are the Locations of this Clinical Trial?

• Rochester, MN
• Scottsdale and Phoenix, AZ

Last updated: 02/05/2008