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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

The subjects will be given orally placebo twice a day for 2 days, and a single 10 mg dose of rosuvastatin.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

one tablet of placebo twice daily for two days

Rosuvastatin

Intervention Type DRUG

10 mg tablet, single dose

Ticagrelor

The subjects will be given orally 90 mg ticagrelor twice a day for 2 days, and a single 10 mg dose of rosuvastatin.

Group Type ACTIVE_COMPARATOR

Ticagrelor

Intervention Type DRUG

Intervention Description: 90 mg tablet twice daily for two days

Rosuvastatin

Intervention Type DRUG

10 mg tablet, single dose

Interventions

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Placebo

one tablet of placebo twice daily for two days

Intervention Type DRUG

Ticagrelor

Intervention Description: 90 mg tablet twice daily for two days

Intervention Type DRUG

Rosuvastatin

10 mg tablet, single dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes