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Study for Identifying Optimal Simvastatin Formulation for Uniform Time to Maximum Plasma Concentration

Primary Purpose

Celiac Disease

Status

Terminated

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

Simvastatin

About this trial

This is an interventional diagnostic trial for Celiac Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

If the subject is female, she is eligible to enter and participate in this study if she is physiologically incapable of becoming pregnant or has a negative urine pregnancy test at screening and at baseline visit
Negative Serology for Hepatitis B/C, HIV
Non-OATP1B1*5 carriers
Negative Serology for anti-transglutaminase IgA antibody, and normal levels of total IgA
For subjects with celiac disease, also
- Diagnosis of celiac disease confirmed by medical history, histological evaluation of small intestinal mucosa on small bowel biopsy, and abnormal anti-transglutaminase antibody titers
- Followed a gluten-free diet for at least one year, as verified by normal anti-transglutaminase antibody levels, Marsh 0-1 score on a follow-up biopsy within the past 12 months, and absence of any clinical signs or symptoms of celiac disease observed at diagnosis

Exclusion criteria:

Current smoker or quit smoking less than 2 years ago
Female breastfeeding or disagrees to use an effective mechanical contraceptive method (e.g. diaphragm or nonhormonal intrauterine device in combination with preservative)
Presence of any known on-going disease which is judged to be relevant according to the investigator, besides celiac disease for the cohort of celiac patients in remission
State after operations of the stomach or bowel (exception: appendectomy)
Participation in any other clinical trial with investigational or approved drugs within the last month before the study
Regular alcohol consumption of more than 25 g / day
Use of any prescription or non-prescription drugs (including herbal supplements) must be discontinued 30 days prior to study (exceptions: paracetamol and NSAIDs, not taken longer than 2 days in a row and not taken within the last 3 days before the study)
Consumption of grapefruit, star fruit, grapefruit juice, or star fruit juice must be discontinued 7 days prior to the study

Sites / Locations

University Hospital Zurich, University Hospital Zurich, Gastroenterology and Hepatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liquid formulation of Simvastatin

Tablet formulation of Simvastatin

Arm Description

Outcomes

Primary Outcome Measures

Peak plasma concentration (Cmax) of simvastatin

Determination of time-dependent concentrations of simvastatin in collected serum of each subject following oral administration of two different formulations and two different doses of simvastatin

Secondary Outcome Measures

Full Information

NCT ID

NCT01642862

First Posted

July 10, 2012

Last Updated

June 2, 2015

Sponsor

University of Zurich

Collaborators

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT01642862

Brief Title

Study for Identifying Optimal Simvastatin Formulation for Uniform Time to Maximum Plasma Concentration

Official Title

A Phase I, Randomized, Open Label, Mono-centered, Prospective Study to Evaluate the Pharmacokinetics of Different Formulations and Doses of Simvastatin in Healthy Subjects and in Subjects With Celiac Disease in Remission

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Terminated

Why Stopped

Low recruitment rate

Study Start Date

July 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

Collaborators

Stanford University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The inter- and intra-variability in the pharmacokinetic parameters of different formulations and doses of simvastatin in healthy subjects and in subjects with celiac disease in remission will be evaluated. Additionally, baseline values of pharmacokinetic parameters of simvastatin for both study groups will be determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Celiac Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liquid formulation of Simvastatin

Arm Type

Experimental

Arm Title

Tablet formulation of Simvastatin

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Intervention Description

Comparison of pharmacokinetic parameters of different formulations (liquid vs tablet) and doses (20 or 40 mg) of simvastatin after single oral administration of the drug

Primary Outcome Measure Information:

Title

Peak plasma concentration (Cmax) of simvastatin

Description

Determination of time-dependent concentrations of simvastatin in collected serum of each subject following oral administration of two different formulations and two different doses of simvastatin

Time Frame

0, 15, 30, 60, 90, 120, 180 minutes post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: If the subject is female, she is eligible to enter and participate in this study if she is physiologically incapable of becoming pregnant or has a negative urine pregnancy test at screening and at baseline visit Negative Serology for Hepatitis B/C, HIV Non-OATP1B1*5 carriers Negative Serology for anti-transglutaminase IgA antibody, and normal levels of total IgA For subjects with celiac disease, also Diagnosis of celiac disease confirmed by medical history, histological evaluation of small intestinal mucosa on small bowel biopsy, and abnormal anti-transglutaminase antibody titers Followed a gluten-free diet for at least one year, as verified by normal anti-transglutaminase antibody levels, Marsh 0-1 score on a follow-up biopsy within the past 12 months, and absence of any clinical signs or symptoms of celiac disease observed at diagnosis Exclusion criteria: Current smoker or quit smoking less than 2 years ago Female breastfeeding or disagrees to use an effective mechanical contraceptive method (e.g. diaphragm or nonhormonal intrauterine device in combination with preservative) Presence of any known on-going disease which is judged to be relevant according to the investigator, besides celiac disease for the cohort of celiac patients in remission State after operations of the stomach or bowel (exception: appendectomy) Participation in any other clinical trial with investigational or approved drugs within the last month before the study Regular alcohol consumption of more than 25 g / day Use of any prescription or non-prescription drugs (including herbal supplements) must be discontinued 30 days prior to study (exceptions: paracetamol and NSAIDs, not taken longer than 2 days in a row and not taken within the last 3 days before the study) Consumption of grapefruit, star fruit, grapefruit juice, or star fruit juice must be discontinued 7 days prior to the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Rogler, Prof MD PhD

Organizational Affiliation

University Hospital Zurich, Gastroenterology and Hepatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Zurich, University Hospital Zurich, Gastroenterology and Hepatology

City

Zurich

State/Province

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

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Study for Identifying Optimal Simvastatin Formulation for Uniform Time to Maximum Plasma Concentration

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