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

NCT06469450 | Recruiting Phase 1

• 1 other identifier: KF2023#1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Lipid trafficking score LT-Mo

  The primary outcome measurement is the "lipid trafficking score LT-Mo" is a combination of LDL uptake and lipid droplet quantifications in monocytes. The participants provide blood samples before starting the atorvastatin intervention, each week when taking atorvastatin (4 times in total), and one week after the end of the intervention.

  Baseline and once a week for 5 weeks

Secondary Outcomes (3)

• Leukocyte LDL uptake

  Baseline and once a week for 5 weeks

• Leukocyte lipid storage

  Baseline and once a week for 5 weeks

• Atorvastatin plasma concentration

  Once a week during the 4 week atorvastatin treatment

Study Arms (1)

Atorvastatin

EXPERIMENTAL

atorvastatin 40 mg daily for 28 days

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

one 40 mg atorvastatin tablet once daily for 28 days

Atorvastatin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• a signed written informed consent
• age 18-40 years
• healthy, and
• 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.
• Fully vaccinated against COVID-19.

You may not qualify if:

• significant disease
• smoking
• SLCO1B1 poor function genotype
• oral contraception or other continuous medication
• pregnancy, planning of pregnancy or breastfeeding
• participating in a clinical trial less than 3 months ago
• donating blood less than 3 months ago
• marked obesity
• anticipated difficulties in drawing blood samples
• weight less than 45 kg
• BMI less than 18.5 kg/m2 or
• inadequate Finnish language skills

Sponsors & Collaborators

• Mikko Niemi: lead
• University of Helsinki: collaborator

Study Sites (1)

Department of Clinical Pharmacology

Helsinki, 00290, Finland

RECRUITING

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Mikko Niemi, MD, PhD

CONTACT

+35894711; mikko.niemi@hus.fi

Anssi Mykkänen, MD

CONTACT

+35894711; anssi.mykkanen@hus.fi

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: June 21, 2024
• Study Start: April 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)