Simvastatin Metabolism as a Test for CD Activity (IRB 15-... | NCT03011931

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

NCT03011931

Sponsor

Entero Therapeutics

Status

Completed

Last Update Posted

Aug 5, 2024Actual

Enrollment

40Actual

Phase

Early Phase 1

Conditions

Celiac Disease

Interventions

Simvastatin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Jan 2019Actual

Completion Date

Feb 2019Actual

First Submitted Date

Oct 3, 2016

First Submission Date that Met QC Criteria

Jan 3, 2017

First Posted Date

Jan 6, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2024

Last Update Posted Date

Aug 5, 2024Actual

Name	Class
Immunogenics, LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simvastatin	Experimental	Simvastatin tablet, 20 mg, one time by mouth	Drug: Simvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simvastatin	Drug	20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review	Simvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare simvastatin metabolism with intestinal biopsies		Within one month of visit

Secondary Outcomes

Measure	Description	Time Frame
Villous height and crypt depth	As measured in intestinal biopsies	Within 1 month of visit
Dietary interview	To determine whether the patient is strictly adherent, mostly adherent or non-adherent to a gluten-free diet

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1st 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph A Murray, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

References Module

Citations

Not provided

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic