HealthyPhase 1NCT03728101
Drug Interaction Study of Simvastatin and Dabigatran
A Phase 1 study testing Simvastatin, Dabigatran Etexilate in people with Healthy, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
The aim of the study is to evaluate the effect of simvastatin on the pharmacokinetics and pharmacodynamics of dabigatran in healthy male adults Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Simvastatin, Dabigatran Etexilate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2018to 15 Dec 2018
- 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 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 19 and 50 years
- Subjects with body mass index (BMI) between 18.5 and 29.9 kg/m2 and weight more than 50 kg
- Subjects who agree with performing contraception during the study
- Subjects who agreed with written informed consent
Who cannot join
- Subjects who have a current or prior history of cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, skin, psychiatric, or neurological diseases that is clinically significant
- Subjects who have clinically significant allergic history or allergy to simvastatin, dabigatran, or other components of drug
- Creatinine clearance is below 60 ml/min
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) is more than 2-fold of upper limit or normal range
- Subjects who have clinically significant bleeding
- Subjects at risk of bleeding
Show all 11Show fewer
- Subjects who took drugs which significantly interact with simvastatin or dabigatran prior to dosing
- Whole blood donation within 60 days prior to dosing, or apheresis donation within 20 days prior to dosing
- Participated in a previous clinical trial within 90 days prior to dosing
- Subjects with a history of alcohol abuse
- Subjects who are determined by investigator's decision as unsuitable for clinical trial participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Evaluate the Effect of Simvastatin on the Pharmacokinetics and Pharmacodynamics of Dabigatran in Healthy Male Adults
The aim of the study is to evaluate the effect of simvastatin on the pharmacokinetics and pharmacodynamics of dabigatran in healthy male adults
Read the detailed description
Pharmacokinetics and pharmacodynamics of dabigatran without coadministration of simvastatin will be compared with those after multiple administration of simvastatin.
- Conditions
- Healthy
- Being tested
- Simvastatin, Dabigatran Etexilate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin, Dabigatran EtexilateDrug
The subjects receive dabigatran etexilate with and without simvastatin administration
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | * Dabigatran etexilate
* Simvastatin + Dabigatran etexilate Receives: Drug: Simvastatin, Dabigatran Etexilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum plasma concentration
Measured: 24 hours
AUC
Area under the plasma concentration versus time curve
Measured: 24 hours, zero to infinite
Secondary outcomes (6)
aPTT
Activated partial thromboplastin time
Measured: 24 hours
TT
Thrombin time
Measured: 24 hours
lag time
thrombin generation assay
Measured: 24 hours
peak thrombin
thrombin generation assay
Measured: 24 hours
velocity index
thrombin generation assay
Measured: 24 hours
area under the curve
thrombin generation assay
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start16 Nov 2018
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyewon Chung, Korea University Guro Hospital
- Investigators
- Hyewon Chung, MD, PhD, Principal investigator, Clinical Instructor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728101
- Sponsor's protocol ID
- SD-DDI
- Status last verified
- Mar 2019
- First submitted
- 29 Oct 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effect of Simvastatin on the Pharmacokinetics and Pharmacodynamics of Dabigatran in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT03728101
- Acronym / sponsor ID
- SD-DDI
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 1 Nov 2018 (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 aim of the study is to evaluate the effect of simvastatin on the pharmacokinetics and pharmacodynamics of dabigatran in healthy male adults
Detailed description
Pharmacokinetics and pharmacodynamics of dabigatran without coadministration of simvastatin will be compared with those after multiple administration of simvastatin.
Study design
- Primary purpose
- Basic science
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: Simvastatin, Dabigatran Etexilate* Dabigatran etexilate * Simvastatin + Dabigatran etexilate |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects between the ages of 19 and 50 years
- Subjects with body mass index (BMI) between 18.5 and 29.9 kg/m2 and weight more than 50 kg
- Subjects who agree with performing contraception during the study
- Subjects who agreed with written informed consent
Key exclusion criteria (11 listed)
- Subjects who have a current or prior history of cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, skin, psychiatric, or neurological diseases that is clinically significant
- Subjects who have clinically significant allergic history or allergy to simvastatin, dabigatran, or other components of drug
- Creatinine clearance is below 60 ml/min
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) is more than 2-fold of upper limit or normal range
- Subjects who have clinically significant bleeding
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 |
|---|---|---|
| Simvastatin, Dabigatran EtexilateThe subjects receive dabigatran etexilate with and without simvastatin administration | Drug | Single arm |
Primary outcome
Cmax
Time frame: 24 hours
maximum plasma concentration
AUC
Time frame: 24 hours, zero to infinite
Area under the plasma concentration versus time curve
6 secondary outcomes
aPTT
Time frame: 24 hours
TT
Time frame: 24 hours
lag time
Time frame: 24 hours
peak thrombin
Time frame: 24 hours
velocity index
Time frame: 24 hours
area under the curve
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
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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.
Hyewon Chung, MD, PhD principal investigator
Clinical Instructor
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 Simvastatin, Dabigatran Etexilate in people with Healthy, run by Korea University Guro Hospital at 1 site in South Korea.
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 4 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: finished, as of the sponsor's last update on 12 Mar 2019. 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 South Korea. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 12 Mar 2019.