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

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05373277

Collaborator

University of Helsinki (Other)

Enrollment

Location

Arms

7.7

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Drug: Placebo Drug: Ticagrelor Drug: Rosuvastatin	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

KF2019#1-tutkimus: Verihiutaleiden estäjän Vaikutus kolesterolilääkkeeseen

Anticipated Study Start Date :

May 11, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo The subjects will be given orally placebo twice a day for 2 days, and a single 10 mg dose of rosuvastatin.	Drug: Placebo one tablet of placebo twice daily for two days Drug: Rosuvastatin 10 mg tablet, single dose
Active Comparator: Ticagrelor 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 Intervention Description: 90 mg tablet twice daily for two days Drug: Rosuvastatin 10 mg tablet, single dose

Arm

Intervention/Treatment

Placebo Comparator: Placebo

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

Drug: Placebo

one tablet of placebo twice daily for two days

Drug: Rosuvastatin

10 mg tablet, single dose

Active Comparator: Ticagrelor

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

Intervention Description: 90 mg tablet twice daily for two days

Drug: Rosuvastatin

10 mg tablet, single dose

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Pharmacology	Helsinki		Finland	00290

Sponsors and Collaborators

Helsinki University Central Hospital
University of Helsinki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mikko Niemi, Professor, head physician, Helsinki University Central Hospital

ClinicalTrials.gov Identifier:

NCT05373277

Other Study ID Numbers:

KF2019#1

First Posted:

May 13, 2022

Last Update Posted:

May 13, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Ticagrelor

Rosuvastatin Calcium

Study Results

No Results Posted as of May 13, 2022