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

NCT05373277 | Unknown Phase 1

• 1 other identifier: KF2019#1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration - time curve of rosuvastatin

  Prior to and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 23, and 47 hours after administration of rosuvastatin

Secondary Outcomes (1)

• Peak plasma concentration, half-life, time to peak plasma concentration, amount excreted, and renal clearance of rosuvastatin

  Prior to and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 23, and 47 hours after administration of rosuvastatin

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Rosuvastatin

Ticagrelor

ACTIVE COMPARATOR

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

Drug: Ticagrelor; Drug: Rosuvastatin

Interventions

Placebo DRUG

one tablet of placebo twice daily for two days

Placebo

Ticagrelor DRUG

Intervention Description: 90 mg tablet twice daily for two days

Ticagrelor

Rosuvastatin DRUG

10 mg tablet, single dose

Placebo; Ticagrelor

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator

Study Sites (1)

Department of Clinical Pharmacology

Helsinki, 00290, Finland

RECRUITING

MeSH Terms

Interventions

Ticagrelor; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Mikko Niemi, MD, PhD

CONTACT

+35894711; mikko.niemi@hus.fi

Minna Lehtisalo, MD

CONTACT

+35894711; minna.lehtisalo@hus.fi

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head physician

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 13, 2022
• Study Start: May 11, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)