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

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01642862
• Other study ID #: CYPCEL-1103
• Status: Terminated
• Phase: Phase 1
• First received: July 10, 2012
• Last updated: June 2, 2015
• Start date: July 2012
• Est. completion date: February 2014

Study information

• Verified date: May 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: February 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, University Hospital Zurich, Gastroenterology and Hepatology	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Stanford University

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0, 15, 30, 60, 90, 120, 180 minutes post-dose	No