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RECRUITING
NCT06469450
PHASE1

KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts

Sponsor: Mikko Niemi

View on ClinicalTrials.gov

Summary

A majority of high-risk patients does not achieve their cholesterol target levels and most of these patients do not receive more effective combination therapy, which goes beyond statin monotherapy. Large interindividual differences in treatment outcomes have been observed for patients receiving statins. Statins block cholesterol synthesis and increase cellular low-density lipoprotein (LDL) uptake. Importantly, LDL uptake is highly divergent in individuals.The aim of this trial is to investigate how atorvastatin influences leukocyte readouts of LDL uptake and lipid storage in humans. The trial is a single-arm, open-label, interventional trial. A total of 15 healthy volunteers will receive 40 mg atorvastatin once a day for 4 weeks. The participants will provide blood samples before starting the atorvastatin intervention, each week when taking atorvastatin, and one week after the end of the intervention for the measurement of leukocyte readouts of LDL uptake and lipid storage.

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2024-04-20

Completion Date

2024-12-31

Last Updated

2024-06-21

Healthy Volunteers

Yes

Interventions

DRUG

Atorvastatin

one 40 mg atorvastatin tablet once daily for 28 days

Locations (1)

Department of Clinical Pharmacology

Helsinki, Finland