Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amgen | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full group | Experimental | Evolocumab 140 mg subcutaneously. Två months later, repetitive doses of atorvastatin 40 mg once daily. After continued atorvastatin, evolocumab 140 mg is added subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab | Drug | See arm description |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Cholesterol metabolism effect | Effect of these treatments on markers for cholesterol metabolism, namely lathosterol and campesterol, measured as change from baseline concentration (mg/mmol) per unit time. | 32 hours |
| Bile acid metabolism effect | Effect of these treatments on markers for bile acid metabolism, namely C4; measured as change from baseline concentration (mg/mmol) per unit time. | 32 hours |
| Bile acid metabolism effect | Effect of these treatments on markers for cholesterol and bile acid metabolism, namely bile acids; measured as change from baseline concentration (mikromol/ml) per unit time. | 32 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erik Hoffmann, MD | Contact | +46 8-517 700 00 | erik.hoffmann@ki.se | |
| Mats Eriksson, MD PhD | Contact | mats.eriksson@ki.se |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C577155 | evolocumab |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |