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

• Sponsor: Immunogenics, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03011931
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 35.1
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Celiac Disease	Drug: Simvastatin	Early Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Simvastatin Metabolism as a Test for Celiac Disease Activity
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Jan 1, 2019
• Actual Study Completion Date: Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Simvastatin Simvastatin tablet, 20 mg, one time by mouth	Drug: Simvastatin; 20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review; Other Names: Zocor

Outcome Measures

Primary Outcome Measures

1. Compare simvastatin metabolism with intestinal biopsies [Within one month of visit]

Secondary Outcome Measures

1. Villous height and crypt depth [Within 1 month of visit]

   As measured in intestinal biopsies

2. Dietary interview [At initial visit]

   To determine whether the patient is strictly adherent, mostly adherent or non-adherent to a gluten-free diet

3. Urinalysis [Prior to administration of simvastatin and at the 3-hour mark]

   Looking for traces of gluten peptides

4. Serologic testing [Prior to administration of simvastatin]

   tTG IgA titer level determination

5. DNA sampling [Prior to administration of simvastatin]

   Genetic testing associated with celiac disease (DQ2 and DQ8)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Immunogenics, LLC

Investigators

• Principal Investigator: Joseph A Murray, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Immunogenics, LLC
• ClinicalTrials.gov Identifier: NCT03011931
• Other Study ID Numbers: 15-007568
• First Posted: Jan 6, 2017
• Last Update Posted: Jan 18, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Celiac Disease; Simvastatin

Study Results

No Results Posted as of Jan 18, 2020