KF2019#1-trial: Effects of a Thrombocyte Inhibitor on a Cholesterol-lowering Drug

Pharmacokinetics Clinical Trial

— KF2019#1  

Official title:

KF2019#1-tutkimus: Verihiutaleiden estäjän Vaikutus kolesterolilääkkeeseen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05373277
• Other study ID #: KF2019#1
• Status: Recruiting
• Phase: Phase 1
• Start date: May 11, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Helsinki University Central Hospital
• Contact: Mikko Niemi, MD, PhD
• Phone: +35894711
• Email: mikko.niemi[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The cholesterol-lowering drug rosuvastatin is a substrate of the breast cancer resistance protein (BCRP). BCRP is an efflux transporter expressed e.g. in the small intestine. It limits the oral bioavailability of rosuvastatin by transporting rosuvastatin from enterocytes back to the gut lumen. Inhibition of BCRP can increase rosuvastatin bioavailability and systemic concentrations. Ticagrelor is a platelet aggregation inhibitor used in treatment and prevention of atherothrombotic events. Ticagrelor may inhibit BCRP in humans. This study is aimed to investigate the possible interaction of rosuvastatin with ticagrelor. Ten healthy male or female non-smoking volunteers aged 18-40 years are taken into the study. Primary endpoint is area under the plasma concentration-time curve of rosuvastatin.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• Age 18-40

• Healthy

• Systolic blood pressure =100 mmHg

• 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.

Exclusion Criteria:

• Significant disease

• Abnormal result from the Helsinki University Hospital bleeding questionnaire

• Smoking

• Using oral contraception pills or other regular medication

• Pregnancy (current or planned) or nursing

• Participation in any other studies involving investigational or marketed drug products within three months prior to the entry into this study

• Donation of blood within three months prior to the entry into this study

• Significant overweight / small or hard-to-find veins

• Weight < 45 kg

• BMI < 18.5 kg/m2

• Insufficient Finnish language skills

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• Placebo
one tablet of placebo twice daily for two days
• Ticagrelor
Intervention Description: 90 mg tablet twice daily for two days
• Rosuvastatin
10 mg tablet, single dose

Locations

Country	Name	City	State
Finland	Department of Clinical Pharmacology	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration - time curve of rosuvastatin		Prior to and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 23, and 47 hours after administration of rosuvastatin
Secondary	Peak plasma concentration, half-life, time to peak plasma concentration, amount excreted, and renal clearance of rosuvastatin		Prior to and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 23, and 47 hours after administration of rosuvastatin