Acute Metabolic Effects of Evolocumab and Atorvastatin
Conditions
Brief summary
Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.
Interventions
DRUGEvolocumab
See arm description
Sponsors
Amgen
Region Stockholm
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male * \>18 years of age
Exclusion criteria
* Cardiovascular disease * Cerebrovascular disease (e.g. stroke, prior aneurysm) * Pulmonary disease (e.g. pulmonary hypertension, COPD) * Metabolic disease (incl. but not limited to Cushing disease, Diabetes) * Renal disease (by Chronic kidney disease criteria) * Active inflammatory bowel syndrome * Cancer * Pregnancy * Smoker * Any chronic medication use * Steroid treatment for the last six months or hormone replacement therapy * Coagulopathy * Musculoskeletal or neurologic disease * Know allergy against any of the studied substances * Inclusion in any other concurrent medical research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol metabolism effect | 32 hours | Effect of these treatments on markers for cholesterol metabolism, namely lathosterol and campesterol, measured as change from baseline concentration (mg/mmol) per unit time. |
| Bile acid metabolism effect | 32 hours | Effect of these treatments on markers for bile acid metabolism, namely C4; measured as change from baseline concentration (mg/mmol) per unit time. |
Contacts
Primary ContactErik Hoffmann, MD
Backup ContactMats Eriksson, MD PhD
Outcome results
None listed