Study for Identifying Optimal Simvastatin Formulation for... | NCT01642862

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

NCT01642862

Sponsor

University of Zurich

Status

Terminated

Last Update Posted

Jun 3, 2015Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Celiac Disease

Interventions

Simvastatin

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low recruitment rate

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2013Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jul 10, 2012

First Submission Date that Met QC Criteria

Jul 13, 2012

First Posted Date

Jul 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2015

Last Update Posted Date

Jun 3, 2015Estimated

Name	Class
Stanford University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Label	Type	Description	Intervention Names
Liquid formulation of Simvastatin	Experimental		Drug: Simvastatin
Tablet formulation of Simvastatin	Active Comparator		Drug: Simvastatin

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic