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

Helsinki University Central Hospital (HUCH)

Status and phase: Unknown; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Ticagrelor; Drug: Rosuvastatin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05373277

KF2019#1

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Rosuvastatin

Drug: Placebo

Ticagrelor

Active Comparator group

Description:

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

Treatment:

Drug: Ticagrelor

Drug: Rosuvastatin