HealthyPhase 1SMCCPT-100NCT01870466
Pharmacodynamic Drug Interaction Between Cilostazol and Statins
A Phase 1 study testing Cilostazol, Simvastatin and Rosuvastatin in people with Healthy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cilostazol, Simvastatin and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Dec 2013
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 20 - 55 years
- A body mass index in the range 18.5 - 27 kg/m2
- Willingness to participate during the entire study period
- Written informed consent after being fully informed about the study procedures
Who cannot join
- Any past medical history of hepatic, renal, neurologic, cardiovascular, respiratory, endocrine, hemato-oncologic or psychiatric disease
- Active bleeding or bleeding tendency
- History of gastrointestinal disease or surgery possibly affecting drug absorption
- History of clinically significant drug hypersensitivity
- Use of medication within 7 days before the first dose
- Heavy drinker (>140 g/week)
- Whole blood donation during 60 days before the study
- Judged not eligible for study participation by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacodynamic Drug Interaction Between Cilostazol and Statins in Healthy Male Volunteer
The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in healthy male subjects.
Read the detailed description
Subjects suitable for this study will visit to the Clinical Trial Center, Samsung Medical Center for 7 days and pharmacodynamic samplings will be performed following the administration of study drugs.
- Conditions
- Healthy
- Being tested
- Cilostazol, Simvastatin, Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilostazolDrug
Also called cilostazol (C); Plettal 100 mg
cilostazol bid for 7 days
SimvastatinDrug
Also called simvastatin (S); Zocor 40 mg
simvastatin qd for 7 days
RosuvastatinDrug
Also called Rosuvastatin (R); Crestor 20 mg
rosuvastatin qd for 7 days
| Study group | Role | What they receive |
|---|---|---|
| C -> C + S | Experimental | cilostazol (C) in period 1, cilostazol + simvastatin (C+S) in period 2 Receives: Drug: Cilostazol; Drug: Simvastatin |
| C + S -> C | Experimental | cilostazol + simvastatin (C+S) in period 1, cilostazol (C) in period 2 Receives: Drug: Cilostazol; Drug: Simvastatin |
| S -> S + C | Experimental | simvastatin (S) in period 1, simvastatin + cilostazol (S+C) in period 2 Receives: Drug: Cilostazol; Drug: Simvastatin |
| C + S -> S | Experimental | cilostazol + simvastatin (C+S) in period 1, simvastatin (S) in period 2 Receives: Drug: Cilostazol; Drug: Simvastatin |
| R -> C + R | Experimental | rosuvastatin (R) in period 1, cilostazol + rosuvastatin (C+R) in period 2 Receives: Drug: Cilostazol; Drug: Rosuvastatin |
| C + R -> R | Experimental | cilostazol + rosuvastatin (C+R) in period 1, rosuvastatin (R) in period 2 Receives: Drug: Cilostazol; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid lowering effect
lipid panel
Measured: 7 days
Secondary outcomes (1)
anti-platelet effect
platelet aggregation test
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 posted6 Jun 2013 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionDec 2013
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jae-Wook Ko, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870466
- Sponsor's protocol ID
- 2011-11-004
- Acronym
- SMCCPT-100
- Status last verified
- May 2015
- First submitted
- 4 May 2012
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacodynamic Drug Interaction Between Cilostazol and Statins in Healthy Male Volunteer
- ClinicalTrials.gov ID
- NCT01870466
- Acronym / sponsor ID
- SMCCPT-100 / 2011-11-004
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Jun 2013 (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.
The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in healthy male subjects.
Detailed description
Subjects suitable for this study will visit to the Clinical Trial Center, Samsung Medical Center for 7 days and pharmacodynamic samplings will be performed following the administration of study drugs.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| C -> C + S | Experimental | Drug: Cilostazol, Drug: Simvastatincilostazol (C) in period 1, cilostazol + simvastatin (C+S) in period 2 |
| C + S -> C | Experimental | Drug: Cilostazol, Drug: Simvastatincilostazol + simvastatin (C+S) in period 1, cilostazol (C) in period 2 |
| S -> S + C | Experimental | Drug: Cilostazol, Drug: Simvastatinsimvastatin (S) in period 1, simvastatin + cilostazol (S+C) in period 2 |
| C + S -> S | Experimental | Drug: Cilostazol, Drug: Simvastatincilostazol + simvastatin (C+S) in period 1, simvastatin (S) in period 2 |
| R -> C + R | Experimental | Drug: Cilostazol, Drug: Rosuvastatinrosuvastatin (R) in period 1, cilostazol + rosuvastatin (C+R) in period 2 |
| C + R -> R | Experimental | Drug: Cilostazol, Drug: Rosuvastatincilostazol + rosuvastatin (C+R) in period 1, rosuvastatin (R) in period 2 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects aged 20 - 55 years
- A body mass index in the range 18.5 - 27 kg/m2
- Willingness to participate during the entire study period
- Written informed consent after being fully informed about the study procedures
Key exclusion criteria (8 listed)
- Any past medical history of hepatic, renal, neurologic, cardiovascular, respiratory, endocrine, hemato-oncologic or psychiatric disease
- Active bleeding or bleeding tendency
- History of gastrointestinal disease or surgery possibly affecting drug absorption
- History of clinically significant drug hypersensitivity
- Use of medication within 7 days before the first dose
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 |
|---|---|---|
| CilostazolAlso: cilostazol (C); Plettal 100 mgcilostazol bid for 7 days | Drug | C + R -> R, C + S -> C, C + S -> S, C -> C + S, R -> C + R, S -> S + C |
| SimvastatinAlso: simvastatin (S); Zocor 40 mgsimvastatin qd for 7 days | Drug | C + S -> C, C + S -> S, C -> C + S, S -> S + C |
| RosuvastatinAlso: Rosuvastatin (R); Crestor 20 mgrosuvastatin qd for 7 days | Drug | C + R -> R, R -> C + R |
Primary outcome
lipid lowering effect
Time frame: 7 days
lipid panel
1 secondary outcome
anti-platelet effect
Time frame: 7 days
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 27 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.
Jae-Wook Ko, MD, PhD 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 Cilostazol, Simvastatin and Rosuvastatin 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 4 inclusion and 8 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 27 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?
lipid lowering effect (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 27 May 2015.