Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Region Stockholm
• Collaborator: Amgen
• Treatments: Atorvastatin; Evolocumab

Criteria

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