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

Launched by MIKKO NIEMI · Jun 17, 2024

Keywords

ClinConnect Summary

The KF2023#1 trial is studying how a medication called atorvastatin affects the way certain white blood cells in our body take up cholesterol, specifically low-density lipoprotein (LDL), and how they store it. Many patients who are at high risk for heart problems struggle to reach their cholesterol goals, and this trial aims to understand why some people respond better to statins than others. In this study, 15 healthy volunteers will take 40 mg of atorvastatin daily for four weeks, with blood samples collected before they start, weekly during the treatment, and one week after stopping the medication to measure the impact on cholesterol handling in their cells.

To participate in this trial, you need to be between 18 and 40 years old, healthy, and have certain lab test results that meet the study's criteria. Participants also need to be fully vaccinated against COVID-19. If you join, you can expect regular blood tests to track how your body responds to the medication. It's important to note that individuals with significant health issues, smokers, or those on certain medications will not be eligible for this study. Overall, the trial hopes to shed light on how atorvastatin can work differently in individuals, potentially leading to better treatment strategies for managing cholesterol.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. a signed written informed consent
• • 2. age 18-40 years
• • 3. healthy, and
• • 4. Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.
• • 5. Fully vaccinated against COVID-19.
• Exclusion Criteria:
• • 1. significant disease
• • 2. smoking
• • 3. SLCO1B1 poor function genotype
• • 4. oral contraception or other continuous medication
• • 5. pregnancy, planning of pregnancy or breastfeeding
• • 6. participating in a clinical trial less than 3 months ago
• • 7. donating blood less than 3 months ago
• • 8. marked obesity
• • 9. anticipated difficulties in drawing blood samples
• • 10. weight less than 45 kg
• • 11. BMI less than 18.5 kg/m2 or
• • 12. inadequate Finnish language skills