NCT06469450

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Mikko Niemi · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacodynamics

Interventions

Type	Name	Description
DRUG	Atorvastatin	one 40 mg atorvastatin tablet once daily for 28 days

Timeline

• Start date: 2024-04-20
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-06-21
• Last updated: 2024-06-21

Locations

1 site across 1 country: Finland