Effects of atorvastatin on cholesterol uptake in healthy individuals
KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts
This study is testing how a common cholesterol medication called atorvastatin affects cholesterol levels in healthy people over four weeks.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 1 site (Helsinki) |
| Trial ID | NCT06469450 on ClinicalTrials.gov |
What this trial studies
This trial investigates how atorvastatin, a common cholesterol-lowering medication, affects the uptake of low-density lipoprotein (LDL) and lipid storage in leukocytes among healthy volunteers. It is a single-arm, open-label interventional study involving 15 participants who will take 40 mg of atorvastatin daily for four weeks. Blood samples will be collected before the intervention, weekly during treatment, and one week after to measure changes in cellular responses. The study aims to understand the variability in treatment outcomes associated with statin therapy.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18-40 who meet specific laboratory test criteria and are fully vaccinated against COVID-19.
Not a fit: Patients with significant diseases, those who smoke, or individuals on continuous medication will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of statin efficacy and personalized treatment strategies for cholesterol management.
How similar studies have performed: While the approach of studying statin effects is common, the specific focus on leukocyte readouts and individual variability in LDL uptake is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Helsinki
- Department of Clinical Pharmacology — Helsinki, Finland (Recruiting)
Study contacts
- Study coordinator: Mikko Niemi, MD, PhD
- Email: mikko.niemi@hus.fi
- Phone: +35894711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.