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

NCT ID: NCT01642862

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-02-28

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.

Conditions

Celiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Liquid formulation of Simvastatin

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

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

Tablet formulation of Simvastatin

Group Type: ACTIVE_COMPARATOR

Simvastatin

Intervention Type: DRUG

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

Interventions

Simvastatin

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerhard Rogler, Prof MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Gastroenterology and Hepatology

Locations

University Hospital Zurich, University Hospital Zurich, Gastroenterology and Hepatology

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

CYPCEL-1103

Identifier Type: -

Identifier Source: org_study_id