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

NCT ID: NCT06469450

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Atorvastatin

atorvastatin 40 mg daily for 28 days

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

one 40 mg atorvastatin tablet once daily for 28 days

Interventions

Atorvastatin

one 40 mg atorvastatin tablet once daily for 28 days

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Helsinki

OTHER

Sponsor Role: collaborator

Mikko Niemi

OTHER

Sponsor Role: lead

Responsible Party

Mikko Niemi

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Clinical Pharmacology

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Mikko Niemi, MD, PhD

Role: CONTACT

mikko.niemi@hus.fi

+35894711

Anssi Mykkänen, MD

Role: CONTACT

anssi.mykkanen@hus.fi

+35894711

Facility Contacts

Mikko Niemi, MD, PhD

Role: primary

mikko.niemi@hus.fi

+35894711

Anssi Mykkänen, MD

Role: backup

anssi.mykkanen@hus.fi

+35894711

Other Identifiers

KF2023#1

Identifier Type: -

Identifier Source: org_study_id