PharmacokineticsPhase 1KF2019#1NCT05373277
KF2019#1-trial: Effects of a Thrombocyte Inhibitor on a Cholesterol-lowering Drug
A Phase 1 study testing Ticagrelor and Rosuvastatin in people with Pharmacokinetics, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Ticagrelor and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- 11 May 2022to 31 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Department of Clinical Pharmacology
Helsinki, 00290
Mikko Niemi, MD,PhD, +35894711, mikko.niemi@hus.fi
Minna Lehtisalo, MD, +35894711, minna.lehtisalo@hus.fi
About this study
Official title: KF2019#1-tutkimus: Verihiutaleiden estäjän Vaikutus kolesterolilääkkeeseen
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
- Being tested
- Placebo, Ticagrelor, Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
one tablet of placebo twice daily for two days
TicagrelorDrug
Intervention Description: 90 mg tablet twice daily for two days
RosuvastatinDrug
10 mg tablet, single dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The subjects will be given orally placebo twice a day for 2 days, and a single 10 mg dose of rosuvastatin. Receives: 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. Receives: Drug: Ticagrelor; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration - time curve of rosuvastatin
Measured: 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
Measured: Prior to and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 23, and 47 hours after administration of rosuvastatin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start11 May 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Mikko Niemi, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373277
- Sponsor's protocol ID
- KF2019#1
- Acronym
- KF2019#1
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KF2019#1-tutkimus: Verihiutaleiden estäjän Vaikutus kolesterolilääkkeeseen
- ClinicalTrials.gov ID
- NCT05373277
- Acronym / sponsor ID
- KF2019#1 / KF2019#1
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 11 May 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: RosuvastatinThe subjects will be given orally placebo twice a day for 2 days, and a single 10 mg dose of rosuvastatin. |
| Ticagrelor | Active comparator | Drug: Ticagrelor, Drug: RosuvastatinThe subjects will be given orally 90 mg ticagrelor twice a day for 2 days, and a single 10 mg dose of rosuvastatin. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboone tablet of placebo twice daily for two days | Drug | Placebo |
| TicagrelorIntervention Description: 90 mg tablet twice daily for two days | Drug | Ticagrelor |
| Rosuvastatin10 mg tablet, single dose | Drug | Placebo, Ticagrelor |
Primary outcome
Area under the plasma concentration - time curve of rosuvastatin
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 23, and 47 hours after administration of rosuvastatin
1 secondary outcome
Peak plasma concentration, half-life, time to peak plasma concentration, amount excreted, and renal clearance of rosuvastatin
Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 23, and 47 hours after administration of rosuvastatin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ticagrelor and Rosuvastatin in people with Pharmacokinetics, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikko Niemi, MD, PhD (+35894711, mikko.niemi@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration - time curve of rosuvastatin (time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 23, and 47 hours after administration of rosuvastatin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.