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

Early Phase 1

Completed

• Conditions: Celiac Disease
• Interventions: Drug: Simvastatin

• Registration Number: NCT03011931
• Lead Sponsor: Entero Therapeutics

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-06
• Primary Completion: 2019-01
• Study Completion: 2019-02
• Status Verified: 2020-01
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Simvastatin	Simvastatin	Simvastatin tablet, 20 mg, one time by mouth

Primary Outcome Measures

Name	Time	Method
Compare simvastatin metabolism with intestinal biopsies	Within one month of visit

Secondary Outcome Measures

Name	Time	Method
Villous height and crypt depth	Within 1 month of visit	As measured in intestinal biopsies
DNA sampling	Prior to administration of simvastatin	Genetic testing associated with celiac disease (DQ2 and DQ8)
Dietary interview	At initial visit	To determine whether the patient is strictly adherent, mostly adherent or non-adherent to a gluten-free diet
Urinalysis	Prior to administration of simvastatin and at the 3-hour mark	Looking for traces of gluten peptides
Serologic testing	Prior to administration of simvastatin	tTG IgA titer level determination

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States