Actively Recruiting
KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts
Led by Mikko Niemi · Updated on 2024-06-21
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mikko Niemi
Lead Sponsor
U
University of Helsinki
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how atorvastatin, a cholesterol-lowering drug, affects certain immune cells called leukocytes in healthy adults. The study focuses on how atorvastatin influences the uptake of low-density lipoprotein (LDL) cholesterol and lipid storage within these cells. Since many high-risk patients do not meet cholesterol targets with statin alone, this trial helps explore individual differences in response to atorvastatin treatment. It is a Phase 1, single-arm, open-label interventional trial sponsored by Mikko Niemi. Participants will receive one 40 mg atorvastatin tablet daily for 28 days. Blood samples will be taken before starting treatment, weekly during the 4-week atorvastatin period, and one week after stopping the medication. These samples will be tested to measure leukocyte LDL uptake, lipid storage, and atorvastatin levels in the plasma. During the study, participants will provide blood samples regularly to monitor lipid trafficking and leukocyte responses before, during, and after atorvastatin treatment. The main outcome measured is the lipid trafficking score over five weeks. Secondary outcomes include leukocyte LDL uptake, lipid storage, and plasma atorvastatin concentration. The trial will observe all participants for a total of 5 weeks and includes safety monitoring through lab tests and clinical assessments.
CONDITIONS
Brief Title
KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Aged between 18 and 40 years
- Healthy individuals
- Accepted results from lab tests including blood counts, liver enzymes, kidney function, electrolytes, and negative pregnancy test for women
- Fully vaccinated against COVID-19
You will not qualify if you...
- Having any significant disease
- Current smoking
- SLCO1B1 poor function genotype
- Use of oral contraception or other continuous medication
- Pregnancy, planning pregnancy, or breastfeeding
- Participation in a clinical trial within the last 3 months
- Blood donation within the last 3 months
- Marked obesity
- Anticipated difficulties in blood sampling
- Weight less than 45 kg
- Body mass index (BMI) less than 18.5 kg/m2
- Inadequate Finnish language skills
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants take one 40 mg atorvastatin tablet once daily for 28 days.
1 baseline visit and 4 weekly visits during treatment
Trial Site Locations
Total: 1 location
1
Department of Clinical Pharmacology
Helsinki, Finland, 00290
Actively Recruiting
Research Team
M
Mikko Niemi, MD, PhD
A
Anssi Mykkänen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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