Trials / Completed
CompletedNCT03011931
Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]
Simvastatin Metabolism as a Test for Celiac Disease Activity
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Entero Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Simvastatin | 20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2019-01-01
- Completion
- 2019-02-01
- First posted
- 2017-01-06
- Last updated
- 2024-08-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03011931. Inclusion in this directory is not an endorsement.