Status:
UNKNOWN
Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism
Lead Sponsor:
Region Stockholm
Collaborating Sponsors:
Amgen
Conditions:
Acute Metabolic Effects of Evolocumab and Atorvastatin
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
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.
Eligibility Criteria
Inclusion
- Male
- \>18 years of age
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06140095
Start Date
February 1 2024
End Date
December 1 2025
Last Update
November 18 2023
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