Overview

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)