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

Entero Therapeutics

Status and phase: Completed; Early Phase 1

Conditions: Celiac Disease

Treatments: Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03011931

15-007568

Details and patient eligibility

About

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

Full description

A cross sectional design incorporating subjects with active celiac disease and healed celiac disease (based on clinically-obtained biopsies); and healthy individuals.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Simvastatin

Experimental group

Description:

Simvastatin tablet, 20 mg, one time by mouth

Treatment:

Drug: Simvastatin