HealthyPhase 1NCT02143323
A Clinical Study to Explore Biomarkers for Drug-induced Liver Injury (DILI)
A Phase 1 study testing Augmentin tablet in people with Healthy, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows; To evaluate the change of liver function according to glutathione s-transferase (GST) genotype after the multiple administration of amoxicillin/clavulanate. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Augmentin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2013to Sep 2014
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject with sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully informed about the study procedures
- Healthy male of female subjects aged 20 - 45 years
- Subjects whose body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (exclusive)
Who cannot join
- Subject with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
- Subject who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration
- Subject who did blood donation during 1 months before the study or Blood donation during 2 months before the study
- Subject with presence or history of severe adverse reaction to study drug
- Subject who cannot prevent pregnancy during the study period.
- Female subject who are pregnant.
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- Subject who drank over 21 units/week of alcohol or subjects who would not be able to stop drinking alcohol during the hospitalization
- Subject who are Heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization.
- Subject judged not eligible for study participation by investigator.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Jieon Lee
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Clinical Study to Evaluate the Effect of Glutathion S-transferase Polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Amoxicillin/Clavulanate and Explore Biomarkers for Drug-induced Liver Injury (DILI)
This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;
- To evaluate the change of liver function according to glutathione s-transferase (GST) genotype after the multiple administration of amoxicillin/clavulanate.
- To evaluate the intrinsic metabolite, human leukocyte antigen (HLA) genotype, and microRNA (miRNA) based on liver function change as the candidate biomarker for DILI.
- Conditions
- Healthy
- Being tested
- Augmentin tablet
- Keywords
- GST, DILI, biomarker
- Medical subject headings
- Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmentin tabletDrug
Also called Experimental: Augmentin, Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days
| Study group | Role | What they receive |
|---|---|---|
| Glutathione S-Transferase Theta1(GSTT1)/Mu1(GSTM1) wild/wild | Active comparator | Augmentin tablet Receives: Drug: Augmentin tablet |
| GSTT1/GSTM1 wild/null type | Active comparator | Augmentin tablet Receives: Drug: Augmentin tablet |
| GSTT1/GSTM1 null/wild type | Active comparator | Augmentin tablet Receives: Drug: Augmentin tablet |
| GSTT1/GSTM1 null/null type | Active comparator | Augmentin tablet Receives: Drug: Augmentin tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aspartate Aminotransferase (AST)
Measured: 22 days
Alanine Aminotransferase (ALT)
Measured: 22 days
Alkaline phosphatase (ALP)
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startDec 2013
- Primary completionAug 2014
- Study completionSep 2014
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 Seoul National University HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Jin Jang, MD, PhD, Seoul National University Hospital
- Investigators
- In-Jin Jang, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143323
- Sponsor's protocol ID
- DILI_Healthy
- Status last verified
- Dec 2014
- First submitted
- 18 Jan 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Effect of Glutathion S-transferase Polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Amoxicillin/Clavulanate and Explore Biomarkers for Drug-induced Liver Injury (DILI)
- ClinicalTrials.gov ID
- NCT02143323
- Acronym / sponsor ID
- DILI_Healthy
- Conditions
- Healthy
- Keywords
- GST, DILI, biomarker
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 May 2014 (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 has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;
- To evaluate the change of liver function according to glutathione s-transferase (GST) genotype after the multiple administration of amoxicillin/clavulanate.
- To evaluate the intrinsic metabolite, human leukocyte antigen (HLA) genotype, and microRNA (miRNA) based on liver function change as the candidate biomarker for DILI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glutathione S-Transferase Theta1(GSTT1)/Mu1(GSTM1) wild/wild | Active comparator | Drug: Augmentin tabletAugmentin tablet |
| GSTT1/GSTM1 wild/null type | Active comparator | Drug: Augmentin tabletAugmentin tablet |
| GSTT1/GSTM1 null/wild type | Active comparator | Drug: Augmentin tabletAugmentin tablet |
| GSTT1/GSTM1 null/null type | Active comparator | Drug: Augmentin tabletAugmentin tablet |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject with sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully informed about the study procedures
- Healthy male of female subjects aged 20 - 45 years
- Subjects whose body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (exclusive)
Key exclusion criteria (9 listed)
- Subject with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
- Subject who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration
- Subject who did blood donation during 1 months before the study or Blood donation during 2 months before the study
- Subject with presence or history of severe adverse reaction to study drug
- Subject who cannot prevent pregnancy during the study period.
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 |
|---|---|---|
| Augmentin tabletAlso: Experimental: Augmentin, Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days | Drug | GSTT1/GSTM1 null/null type, GSTT1/GSTM1 null/wild type, GSTT1/GSTM1 wild/null type, Glutathione S-Transferase Theta1(GSTT1)/Mu1(GSTM1) wild/wild |
Primary outcome
Aspartate Aminotransferase (AST)
Time frame: 22 days
Alanine Aminotransferase (ALT)
Time frame: 22 days
Alkaline phosphatase (ALP)
Time frame: 22 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 23 Dec 2014.
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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.
In-Jin Jang, MD, PhD principal investigator
Seoul National University Hospital
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 Augmentin tablet in people with Healthy, run by Seoul National University Hospital 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 9 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 23 Dec 2014. 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?
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?
Aspartate Aminotransferase (AST) (time frame: 22 days). The study lists 3 primary outcomes in all. 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 23 Dec 2014.