Effect of Fluvastatin on Brown Fat Activity

• Status: Completed
• Trial end date: 2018-02-19
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to elucidate the effects of Fluvastatin on brown adipose tissue activity in humans.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Zurich
• Collaborator: University of Basel
• Treatments: Fluvastatin

Criteria

Inclusion Criteria:

• Male volunteers (18-40 y)

• body mass index 19 to 27 kg/m²

• Fluent in German or English

Exclusion Criteria:

• Regular physical exercise of more than >150 min of exercise per week.

• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,

• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),

• Clinically indicated intake of the following medications: Corticosteroids, CYP3A4-Inhibitors (Itraconazol, Voriconazol, Fluconazol, Clarithromycin, Erythromycin, Indinavir, Nelfinavir, Ritonavir, Grapefruit juice), Beta-Blocker, Neuroleptics, Tricyclic Antidepressants,

• Known or suspected non-compliance, drug or alcohol abuse,

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,

• Participation in another study with investigational drug within the 30 days preceding and during the present study,

• Participation in another study involving ionizing radiation in the same year,

• Previous enrolment into the current study,

• Enrolment of the investigator, his/her family members, employees and other dependent persons,

• MRI contraindications: Not MRI-compatible metal in the body, cardiac pacemaker, History of surgery with possible metal clips/parts still in the body, claustrophobia.

• Resting pulse rate > 70 bpm

• Known arterial hypertension or resting blood pressure > 130/80 mmHg.

• frequence corrected QT-time (QTc) >430 ms

• Serum creatinine > 1.5x upper limit of norm (ULN), i.e.> 145 µmol/L

• creatine kinase > 1.5x ULN, i.e. > 300 U/L

• aspartate transaminase (ASAT) > 1.5x ULN, i.e. > 51 U/L

• alanine aminotransferase (ALAT) > 1.5x ULN, i.e. > 88 U/L

• Hypothyroidism

• Vitamin D deficiency, Vitamin D3 < 25 nmol/L

• Intake of anticoagulants or inhibitors of platelet aggregation (e.g. Aspirin, clopidogrel).

• Known tendency to form keloids (hypertrophic scar tissue)