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

NCT01642862 | Terminated Phase 1 DMC

• 1 other identifier: CYPCEL-1103
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Liquid formulation of Simvastatin

EXPERIMENTAL

Drug: Simvastatin

Tablet formulation of Simvastatin

ACTIVE COMPARATOR

Drug: Simvastatin

Interventions

Simvastatin 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

Liquid formulation of Simvastatin; Tablet formulation of Simvastatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Stanford University: collaborator

Study Sites (1)

University Hospital Zurich, University Hospital Zurich, Gastroenterology and Hepatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Celiac Disease

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Gerhard Rogler, Prof MD PhD

  University Hospital Zurich, Gastroenterology and Hepatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: February 1, 2014
• Last Updated: June 3, 2015

Record last verified: 2015-05

Locations

CH (1)