Effects of Lovastatin on Human Platelet Proteome

NCT ID: NCT02389868

Last Updated: 2015-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-06-30

Brief Summary

The purpose of this study is to evaluate the effects induced by the cholesterol-reducing drug Lovastatin on the platelet proteome of healthy volunteers. Our results may allow to recognize the cell signalling modifications induced by Lovastatin. Furthermore, the current study aims to characterize the biological and inter-individual variation of platelet's proteome as measured by liquid chromatography-tandem mass spectrometry. Lastly, the exploration of changes induced by Lovastatin on the platelet's proteome may allow the discovery of modifications relative to the effects of statins on hemostasis and the lipid profile.

Conditions

Blood Platelets Proteome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lovastatin

Group Type: EXPERIMENTAL

Lovastatin

Intervention Type: DRUG

Interventions

Lovastatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Being an individual age 18 to 40.
• If applicable, female participants susceptible of becoming pregnant consent to use a highly efficient contraception technique AND an efficient contraception technique during the clinical trial and at least 3 months following ending the consumption of Lovastatin.
• Being able to read and understand French.

Exclusion Criteria

• Having a known history of dyslipidemia.
• In regard of the lipid profile at the first visit, patients that are not comprised between the 5th and the 95th percentile for LDL, HDL or Total cholesterol will be excluded.
• Having a history of hypersensitivity to Lovastatin, to one of the components of this product or to any other statin.
• Being affected by mental retardation.
• Pregnancy or suspicion of pregnancy.
• Having an excessive alcohol consumption (a maximum of 3 drinks a day during the trial will be accepted).
• Planning to perform unusual and very intense physical exercises during the study (ex: running a marathon or an Iron Man).
• Having a history of myopathy, myalgia or elevated creatine kinase (CK).
• In regard of the biochemical tests performed at the first visit, individuals having CK levels three times (or more) superior to the upper normal limit will be excluded.
• Having a personal or family history of hereditary muscular diseases.
• Having a history of renal or hepatic pathology.
• Taking one of the following drugs : any hypolipemic drug, any cytochrome P450 isoform 3A4 inhibitor (itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, erythromycin, clarithromycin, telithromycin, nefazodone and products containing cobicistat), ACE inhibitors, danazol, verapamil, diltiazem, cyclosporin, amiodarone, colchicine, fusidic acid (IV or oral).
• Having a history of hypothyroidism.
• Having had a surgical intervention shortly before the beginning of the clinical trial.
• Suffering from any other acute medical condition.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Mathieu Fradet

MD/MSc student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre de Recherche du CHUS

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

14221

Identifier Type: -

Identifier Source: org_study_id