Effects of Lovastatin on Human Platelet Proteome

NCT02389868 | Completed Phase 2

• 1 other identifier: 14221
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Lovastatin; Proteome; Blood platelets

Outcome Measures

Primary Outcomes (1)

• Change in Signal Intensity Measured for Each Protein Identified by Mass Spectrometry in Blood Platelets Lysates

  Proteins from total platelets lysates will be analyzed by TripleTOF 5600 LC-MS/MS (AB SCIEX). The intensity measured for each identified protein will be recorded in SWATH mode. Intensities measured for each protein before (baseline) and after treatment with lovastatin (at 6 weeks) will be recorded and compared.

  Change from Baseline Protein Level at 6 Weeks

Study Arms (1)

Lovastatin

EXPERIMENTAL

Drug: Lovastatin

Interventions

Lovastatin DRUG

Lovastatin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de Recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Interventions

Lovastatin

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD/MSc student

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 17, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

CA (1)