HealthyPhase 1sibuNCT01421706
Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects
A Phase 1 study testing Sibutramine-clopidogrel and sibutramine-Clarithromycin in people with Healthy, run by Inje University.
Trial summary
Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sibutramine-clopidogrel and sibutramine-Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Jul 2009
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- must be healthy volunteer
Who cannot join
- must not be under 18 years old
About this study
Official title: Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism
Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects
Read the detailed description
- Plasma concentrations of sibutramine and its two active metabolites after single oral dose of sibutramine were determined in Korean healthy male subjects with different CYP2B6 genotypes (CYP2B6*1/*1, *1/*6 and *6/*6), either alone or after four-day pretreatment with clopidogrel or clarithromycin.
- Conditions
- Healthy
- Being tested
- Sibutramine-clopidogrel, sibutramine-Clarithromycin
- Keywords
- clarithromycin, sibutramine, clopidogrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sibutramine-clopidogrelDrug
Sibutramine-clopidogrel
sibutramine-ClarithromycinDrug
sibutramine-Clarithromycin
| Study group | Role | What they receive |
|---|---|---|
| sibutramine-clopidogrel | Active comparator | sibutramine-clopidogrel Receives: Drug: Sibutramine-clopidogrel |
| sibutramine-clarithromycin | Active comparator | sibutramine-clarithromycin Receives: Drug: sibutramine-Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
effects of clopidogrel and clarithromycin on the disposition of sibutramine
the effects of clopidogrel and clarithromycin on the disposition of sibutramine and its two active metabolites M1 and M2 in vivo in relation to CYP2B6*6 genetic polymorphism have been evaluated in Korean healthy subjects.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionJul 2009
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Gook Shin, Inje University
- Investigators
- JaeGook Shin, MD,PhD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421706
- Sponsor's protocol ID
- 08-073
- Acronym
- sibu
- Status last verified
- Sep 2012
- First submitted
- 22 Aug 2011
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism
- ClinicalTrials.gov ID
- NCT01421706
- Acronym / sponsor ID
- sibu / 08-073
- Conditions
- Healthy
- Keywords
- clarithromycin, sibutramine, clopidogrel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Aug 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.
Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects
Detailed description
- Plasma concentrations of sibutramine and its two active metabolites after single oral dose of sibutramine were determined in Korean healthy male subjects with different CYP2B6 genotypes (CYP2B6*1/*1, *1/*6 and *6/*6), either alone or after four-day pretreatment with clopidogrel or clarithromycin.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sibutramine-clopidogrel | Active comparator | Drug: Sibutramine-clopidogrelsibutramine-clopidogrel |
| sibutramine-clarithromycin | Active comparator | Drug: sibutramine-Clarithromycinsibutramine-clarithromycin |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- must be healthy volunteer
Key exclusion criteria (1 listed)
- must not be under 18 years old
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 |
|---|---|---|
| Sibutramine-clopidogrelSibutramine-clopidogrel | Drug | sibutramine-clopidogrel |
| sibutramine-Clarithromycinsibutramine-Clarithromycin | Drug | sibutramine-clarithromycin |
Primary outcome
effects of clopidogrel and clarithromycin on the disposition of sibutramine
Time frame: one year
the effects of clopidogrel and clarithromycin on the disposition of sibutramine and its two active metabolites M1 and M2 in vivo in relation to CYP2B6*6 genetic polymorphism have been evaluated in Korean healthy subjects.
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 18 Sep 2012.
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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.
JaeGook Shin, MD,PhD principal investigator
Inje University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sibutramine-clopidogrel and sibutramine-Clarithromycin in people with Healthy, run by Inje University.
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 1 inclusion and 1 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 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
effects of clopidogrel and clarithromycin on the disposition of sibutramine (time frame: one year). 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 18 Sep 2012.