Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]

• Status: Completed
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Immunogenics, LLC; Mayo Clinic
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

1. Gluten-free diet for at least 1 year

2. Clinical endoscopy within the past month

3. Biopsies must show no villous atrophy or villous blunting

4. Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater

Exclusion Criteria:

1. 1st degree relative with Celiac Disease

2. Positive tTG IgA, already on simvastatin or statin agent

3. Unable to stop non-steroidal or anti-inflammatory drugs

4. Prior history of GI surgery other than appendectomy or cholecystectomy

5. Taking drugs know to inhibit or activate CYP3A4

6. Unable to avoid food known to inhibit CYP3A4

7. History of a reaction to statin drugs in the past

8. Pregnant or nursing women