Status:
UNKNOWN
KF2019#1-trial: Effects of a Thrombocyte Inhibitor on a Cholesterol-lowering Drug
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
University of Helsinki
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief 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 bioava...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05373277
Start Date
May 11 2022
End Date
December 31 2022
Last Update
May 13 2022
Active Locations (1)
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1
Department of Clinical Pharmacology
Helsinki, Finland, 00290