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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Page 1 of 1 (1 locations)

1

Department of Clinical Pharmacology

Helsinki, Finland, 00290