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

This study is currently recruiting participants.
Verified July 2012 by University of Zurich
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01642862
First received: July 10, 2012
Last updated: July 13, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Celiac Disease
 Drug: Simvastatin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

MedlinePlus related topics: Celiac Disease
Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Peak plasma concentration (Cmax) of simvastatin [ Time Frame: 0, 15, 30, 60, 90, 120, 180 minutes post-dose ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liquid formulation of Simvastatin Drug: 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
Active Comparator: Tablet formulation of Simvastatin Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01642862

Contacts
Contact: Belén Morón Flores, PhD +41 (0)44 255 11 11 belen.moron@usz.ch
Contact: Gerhard Rogler, Prof MD PhD gerhard.rogler@usz.ch

Locations
Switzerland
University Hospital Zurich, University Hospital Zurich, Gastroenterology and Hepatology Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Stanford University
Investigators
Principal Investigator: Gerhard Rogler, Prof MD PhD University Hospital Zurich, Gastroenterology and Hepatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01642862     History of Changes
Other Study ID Numbers: CYPCEL-1103
Study First Received: July 10, 2012
Last Updated: July 13, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Simvastatin
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013