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

University of Zurich (UZH)

Status and phase

Terminated

Phase 1

Conditions

Celiac Disease

Treatments

Drug: Simvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01642862

CYPCEL-1103

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts 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