DyslipidemiasPhase 1NCT02431013
Cilostazol-Simvastatin Drug Interaction Study
A Phase 1 study testing Simvastatin, Pravastatin and Cilostazol in people with Dyslipidemias and Peripheral Artery Disease, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
This is a randomized, open-label, single \& multiple-dose, parallel study to investigate the effect of cilostazol on the disposition of simvastatin \& pravastatin in healthy male volunteers Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Peripheral Artery Disease
- What is being tested?
- Simvastatin, Pravastatin and Cilostazol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Aug 2015
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 20 - 45 years
- With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}
- Agreement with written informed consent
Who cannot join
- Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
- Inadequate result of laboratory test (especially, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL)
- Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
- Taking OTC(Over the counter)medicine including oriental medicine within 7 days
- Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
- Subject with known for hypersensitivity reaction to Cilostazol, Simvastatin or Pravastatin
Show all 10Show fewer
- Previous whole blood donation within 60 days or component blood donation within 30 days
- Previous participation of other trial within 90 days
- Continued taking caffeine (caffeine > 5 cup/day), drinking (alcohol > 30 g/day) and severe heavy smoker (cigarette > 1/2 pack per day)
- An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou University Medical Center
Suwon, Gyeonggi-do, 443-380
Doo-Yeoun Cho, MD, +82-31-219-4271, dooycho@ajou.ac.kr
Doo-Yeoun Cho, MD
About this study
Official title: A Randomized, Open-label, Multiple-dose, Parallel Study to Investigate The Effect of Cilostazol on the Disposition of Simvastatin in Healthy Male Volunteers
This is a randomized, open-label, single \& multiple-dose, parallel study to investigate the effect of cilostazol on the disposition of simvastatin \& pravastatin in healthy male volunteers
Read the detailed description
Eligibility for participation of this study will be 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 will be admitted to the Clinical Trial Center of Ajou University Medical Center on the day before dosing (Day -1).
On Day 1, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.
From Day 2 ~ 7, Subjects will be dosed cilostazol 100 mg twice a day. On Day 8, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg with cilostazol 100 mg twice a day. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.
- Conditions
- Dyslipidemias, Peripheral Artery Disease
- Being tested
- Simvastatin, Pravastatin, Cilostazol
- Keywords
- Drug-drug interaction, Pharmacokinetics
- Medical subject headings
- Dyslipidemias, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called S
Simvastatin 40 mg on Day 1 \& Day 8.
PravastatinDrug
Also called P
Pravastatin 20 mg on Day 1 \& Day 8.
CilostazolDrug
Also called C
Cilostazol 100 mg twice a day for 6 days \& on Day 8 with statin.
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin+Cilostazol | Experimental | Simvastatin 40 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Simvastatin 40 mg and Cilostazol 100 mg twice a day on Day 8. Receives: Drug: Simvastatin; Drug: Cilostazol |
| Pravastatin+Cilostazol | Active comparator | Pravastatin 20 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Pravastatin 20 mg and Cilostazol 100 mg twice a day on Day 8. Receives: Drug: Pravastatin; Drug: Cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (area under the time-concentration curve) of Simvastatin
Measured: up to 12 hours after Simvastatin dosing
Secondary outcomes (3)
Cmax (maximum plasma concentration) of Simvastatin
Measured: up to 12 hours after Simvastatin dosing
Cmax (maximum plasma concentration) of Pravastatin
Measured: up to 12 hours after Pravastatin dosing
AUC (area under the time-concentration curve) of Pravastatin
Measured: up to 12 hours after Pravastatin dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doo-Yeoun Cho, Ajou University School of Medicine
- Investigators
- Doo-Yeoun Cho, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431013
- Sponsor's protocol ID
- DDI-103
- Status last verified
- Apr 2015
- First submitted
- 23 Apr 2015
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Parallel Study to Investigate The Effect of Cilostazol on the Disposition of Simvastatin in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02431013
- Acronym / sponsor ID
- DDI-103
- Conditions
- Dyslipidemias, Peripheral Artery Disease
- Keywords
- Drug-drug interaction, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (estimated)
- First posted
- 30 Apr 2015 (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.
This is a randomized, open-label, single \& multiple-dose, parallel study to investigate the effect of cilostazol on the disposition of simvastatin \& pravastatin in healthy male volunteers
Detailed description
Eligibility for participation of this study will be 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 will be admitted to the Clinical Trial Center of Ajou University Medical Center on the day before dosing (Day -1).
On Day 1, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.
From Day 2 ~ 7, Subjects will be dosed cilostazol 100 mg twice a day. On Day 8, Subjects will be dosed simvastatin 40 mg or pravastatin 20 mg with cilostazol 100 mg twice a day. Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 24 hours after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin+Cilostazol | Experimental | Drug: Simvastatin, Drug: CilostazolSimvastatin 40 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Simvastatin 40 mg and Cilostazol 100 mg twice a day on Day 8. |
| Pravastatin+Cilostazol | Active comparator | Drug: Pravastatin, Drug: CilostazolPravastatin 20 mg on Day 1. Cilostazol 100 mg twice a day for 6 days. Pravastatin 20 mg and Cilostazol 100 mg twice a day on Day 8. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects aged 20 - 45 years
- With in 20% of ideal body weight, {Ideal body weight=[height(cm)-100]*0.9}
- Agreement with written informed consent
Key exclusion criteria (10 listed)
- Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present)
- Inadequate result of laboratory test (especially, AST/ALT > 1.25 x UNL, Total bilirubin > 1.5 x UNL)
- Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test
- Taking OTC(Over the counter)medicine including oriental medicine within 7 days
- Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication)
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 |
|---|---|---|
| SimvastatinAlso: SSimvastatin 40 mg on Day 1 \& Day 8. | Drug | Simvastatin+Cilostazol |
| PravastatinAlso: PPravastatin 20 mg on Day 1 \& Day 8. | Drug | Pravastatin+Cilostazol |
| CilostazolAlso: CCilostazol 100 mg twice a day for 6 days \& on Day 8 with statin. | Drug | Pravastatin+Cilostazol, Simvastatin+Cilostazol |
Primary outcome
AUC (area under the time-concentration curve) of Simvastatin
Time frame: up to 12 hours after Simvastatin dosing
3 secondary outcomes
Cmax (maximum plasma concentration) of Simvastatin
Time frame: up to 12 hours after Simvastatin dosing
Cmax (maximum plasma concentration) of Pravastatin
Time frame: up to 12 hours after Pravastatin dosing
AUC (area under the time-concentration curve) of Pravastatin
Time frame: up to 12 hours after Pravastatin dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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.
Doo-Yeoun Cho, MD principal investigator
Ajou University School of Medicine
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, Pravastatin and Cilostazol in people with Dyslipidemias and Peripheral Artery Disease, run by Ajou University School of Medicine 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 3 inclusion and 10 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 1 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doo-Yeoun Cho, MD (+82-31-219-4271, dooycho@ajou.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (area under the time-concentration curve) of Simvastatin (time frame: up to 12 hours after Simvastatin dosing). 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 1 May 2015.