NCT05373277

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

KF2019#1-tutkimus: Verihiutaleiden estäjän Vaikutus kolesterolilääkkeeseen

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pharmacokinetics

Interventions

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

Timeline

• Start date: 2022-05-11
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-05-13
• Last updated: 2022-05-13

Locations

1 site across 1 country: Finland