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

NCT05373277 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-05-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER

  • Helsinki University Central Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-11
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05373277 on ClinicalTrials.gov