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

NCT03011931 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 15-007568
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

• Compare simvastatin metabolism with intestinal biopsies

  Within one month of visit

Secondary Outcomes (5)

• Villous height and crypt depth

  Within 1 month of visit

• Dietary interview

  At initial visit

• Urinalysis

  Prior to administration of simvastatin and at the 3-hour mark

• Serologic testing

  Prior to administration of simvastatin

• DNA sampling

  Prior to administration of simvastatin

Study Arms (1)

Simvastatin

EXPERIMENTAL

Simvastatin tablet, 20 mg, one time by mouth

Drug: Simvastatin

Interventions

Simvastatin DRUG

20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review

Also known as: Zocor

Simvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gluten-free diet for at least 1 year
• Clinical endoscopy within the past month
• Biopsies must show no villous atrophy or villous blunting
• Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater

You may not qualify if:

• st degree relative with Celiac Disease
• Positive tTG IgA, already on simvastatin or statin agent
• Unable to stop non-steroidal or anti-inflammatory drugs
• Prior history of GI surgery other than appendectomy or cholecystectomy
• Taking drugs know to inhibit or activate CYP3A4
• Unable to avoid food known to inhibit CYP3A4
• History of a reaction to statin drugs in the past
• Pregnant or nursing women

Sponsors & Collaborators

• Entero Therapeutics: lead
• Immunogenics, LLC: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• A Study of Simvastatin Metabolism as a Test for Celiac Disease Activity - Mayo Clinic

MeSH Terms

Conditions

Celiac Disease

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Joseph A Murray, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: January 6, 2017
• Study Start: March 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: August 5, 2024

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)