HealthyPhase 1NCT01232023
Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent
A Phase 1 study testing Indobufen in people with Healthy, run by Asan Medical Center at 2 sites in South Korea.
Trial summary
This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects. 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?
- Indobufen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2010to Dec 2010
- 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
- Adult males aged 19 to 50 years at screening.
- Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
- Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
Who cannot join
- Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
- Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Pusan
Sangmin Choe, M.D., Ph.D., 82-55-360-1732
- Recruiting
Asan Medical Center
Seoul
Hyeong-Seok Lim, M.D., Ph.D., 82-2-3010-4613
Hyeong-Seok Lim, M.D., Ph.D.
About this study
This study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects.
- Conditions
- Healthy
- Being tested
- Indobufen
- Keywords
- Indobufen, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndobufenDrug
Single Oral Dose of
| Study group | Role | What they receive |
|---|---|---|
| 100mg | Experimental | Wild type UGT1A : 3 / Variant type UGT1A : 3 Receives: Drug: Indobufen |
| 200mg | Experimental | Wild type UGT1A : 3 / Variant type UGT1A : 3 Receives: Drug: Indobufen |
| 400mg | Experimental | Wild type UGT1A : 3 / Variant type UGT1A : 3 Receives: Drug: Indobufen |
| 800mg | Experimental | Wild type UGT1A : 3 / Variant type UGT1A : 3 Receives: Drug: Indobufen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
AUC, Cmax
Measured: 24 Hours
Secondary outcomes (1)
Pharmacodynamics
Platelet Aggregation Test
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 posted2 Nov 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010 (estimated)
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 Asan 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Hyeong-Seok Lim, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232023
- Sponsor's protocol ID
- 2009-0103
- Status last verified
- Oct 2010
- First submitted
- 1 Nov 2010
- Last updated
- 10 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacokinetic and Pharmacodynamic Characteristics of Indobufen, an Anticoagulant Agent
- ClinicalTrials.gov ID
- NCT01232023
- Acronym / sponsor ID
- 2009-0103
- Conditions
- Healthy
- Keywords
- Indobufen, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (estimated)
- First posted
- 2 Nov 2010 (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 study is designed to evaluate the pharmacokinetic and pharmacodynamic characteristics of indobufen in healthy subjects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 100mg | Experimental | Drug: IndobufenWild type UGT1A : 3 / Variant type UGT1A : 3 |
| 200mg | Experimental | Drug: IndobufenWild type UGT1A : 3 / Variant type UGT1A : 3 |
| 400mg | Experimental | Drug: IndobufenWild type UGT1A : 3 / Variant type UGT1A : 3 |
| 800mg | Experimental | Drug: IndobufenWild type UGT1A : 3 / Variant type UGT1A : 3 |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult males aged 19 to 50 years at screening.
- Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height [cm] - 100)x0.9.
- Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.
Key exclusion criteria (2 listed)
- Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
- Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
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 |
|---|---|---|
| IndobufenSingle Oral Dose of | Drug | 100mg, 200mg, 400mg, 800mg |
Primary outcome
Pharmacokinetics
Time frame: 24 Hours
AUC, Cmax
1 secondary outcome
Pharmacodynamics
Time frame: 24 Hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2010.
- Clinical Research Center, Asan Medical CenterLink provided by the sponsor.
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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.
Hyeong-Seok Lim, M.D., Ph.D. principal investigator
Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Indobufen in people with Healthy, run by Asan Medical Center at 2 sites 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 2 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 10 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (time frame: 24 Hours). 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 10 Nov 2010.