HealthyPhase 1NCT01383395
Effect of Cilostazol on the Pharmacokinetics of Simvastatin
A Phase 1 study testing simvastatin/cilostazol in people with Healthy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 20 to 48 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- simvastatin/cilostazol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Sep 2011
- 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 20 to 48 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 20 - 48 years
- A body mass index (BMI) in the range 19-27 kg/m2
- Provide written informed consent after being fully informed about the study procedures
- Subject without any congenital or chronic disease and with no pathologic symptom in the physical examination
- Determined eligible in the ECG, clinical laboratory tests and urinalysis
Who cannot join
- Use of medication which induces or inhibits drug metabolizing enzyme (CYP3A4 etc.) within 30 days prior to drug dosing
- Use of medication within 10 days before first dose
- Abnormal diet that can influence on tlhe ADME of drugs (grapefruit juice etc.)
- Presence or history of clinically significant allergic disease, alcohol abuse, drug hypersensitivity
- Whole blood donation during 60 days before the study
- Participation in other clinical trial within 90 days prior to scheduled study drug administration
- Subject judged not eligible for study participation by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cilostazol on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects
To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult subjects.
Read the detailed description
Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Samsung Medical Center on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed simvastatin 40 mg orally around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests and pharmacokinetic samplings for simvastatin. Subjects were dosed cilostazol 100 mg in the morning on Day 2 and discharged, and visited Clinical Trials Center on Day 3, Day 4 and Day 5 for the oral administration of cilostazol 100 mg. Subjects was admitted in the evening on day 5 and dosed simvastatin 40 mg plus cilostazol 100 mg concomitantly and scheduled pharmacokinetic sampling for simvastatin was performed. Next morning (Day 7), subjects were discharged
- Conditions
- Healthy
- Being tested
- simvastatin/cilostazol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatin/cilostazolDrug
| Study group | Role | What they receive |
|---|---|---|
| simvastatin/cilostazol | Experimental | simvastatin 40 mg on day 1 and 6, cilostazol 100 mg from day 2 to day 6 Receives: Drug: simvastatin/cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of simvastatin
Plasma concentration of simvastin on day 1 and day 6
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
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.
- More trials run by Samsung Medical CenterThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University
- Responsible party
- Sponsor
- Investigators
- JaeWook Ko, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383395
- Sponsor's protocol ID
- 2011-04-070
- Status last verified
- May 2012
- First submitted
- 27 Jun 2011
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cilostazol on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01383395
- Acronym / sponsor ID
- 2011-04-070
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Inje University
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Jun 2011 (estimated)
- 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.
To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult subjects.
Detailed description
Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Samsung Medical Center on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed simvastatin 40 mg orally around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests and pharmacokinetic samplings for simvastatin. Subjects were dosed cilostazol 100 mg in the morning on Day 2 and discharged, and visited Clinical Trials Center on Day 3, Day 4 and Day 5 for the oral administration of cilostazol 100 mg. Subjects was admitted in the evening on day 5 and dosed simvastatin 40 mg plus cilostazol 100 mg concomitantly and scheduled pharmacokinetic sampling for simvastatin was performed. Next morning (Day 7), subjects were discharged
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| simvastatin/cilostazol | Experimental | Drug: simvastatin/cilostazolsimvastatin 40 mg on day 1 and 6, cilostazol 100 mg from day 2 to day 6 |
Who may qualify
- Ages
- 20 to 48 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects aged 20 - 48 years
- A body mass index (BMI) in the range 19-27 kg/m2
- Provide written informed consent after being fully informed about the study procedures
- Subject without any congenital or chronic disease and with no pathologic symptom in the physical examination
- Determined eligible in the ECG, clinical laboratory tests and urinalysis
Key exclusion criteria (7 listed)
- Use of medication which induces or inhibits drug metabolizing enzyme (CYP3A4 etc.) within 30 days prior to drug dosing
- Use of medication within 10 days before first dose
- Abnormal diet that can influence on tlhe ADME of drugs (grapefruit juice etc.)
- Presence or history of clinically significant allergic disease, alcohol abuse, drug hypersensitivity
- Whole blood donation during 60 days before the study
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/cilostazol | Drug | simvastatin/cilostazol |
Primary outcome
Plasma concentration of simvastatin
Time frame: 7 days
Plasma concentration of simvastin on day 1 and day 6
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 20 May 2015.
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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.
JaeWook Ko, MD principal investigator
Samsung Medical Center
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/cilostazol in people with Healthy, run by Samsung Medical Center 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 5 inclusion and 7 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 20 May 2015. 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?
Plasma concentration of simvastatin (time frame: 7 days). 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 20 May 2015.