OverweightPhase 1NCT03000218
Evaluation of PK and Biomarkers After UDCA Administrations to Subjects Who Are Overweight and Have Liver Problems
A Phase 1 study testing Ursodeoxycholic acid and Metformin in people with Overweight and Abnormal Liver Function Tests, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid multiple administration Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Abnormal Liver Function Tests
- What is being tested?
- Ursodeoxycholic acid and Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Jun 2017
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Subjects aged 18 - 50 years
- A body mass index (BMI) in the range of 25.0 kg/m2 - 30.0 kg/m2.
- A alanine aminotransferase (ALT) in the range of 40 - 200 IU/L
- Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.
Who cannot join
- Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
- Subject judged not eligible for study participation by investigator
Trial locations and contacts
1 site in 1 country.
So Hee Jung contact
Heecahn Lee contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seoul
Jae-Yong Chung, MD, PhD, +82-031-787-3955
Jae-Yong Chung, MD, PhD
About this study
Official title: Clinical Study Evaluating Pharmacokinetics and Biomarkers After Ursodeoxycholic Acid (UDCA) Administration to Subjects Who Are Overweight and Have Liver Problems
A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid multiple administration
Read the detailed description
This study has a randomized, open-label, three-treatment, one-sequence, placebo-controlled, multiple drug administration design. The purpose of this study is as follows; To evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid administration
- Conditions
- Overweight, Abnormal Liver Function Tests
- Being tested
- Ursodeoxycholic acid, Metformin, Placebo
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acidDrug
Also called Ursa tab
Ursodeoxycholic acid 300mg bid for 8 weeks
MetforminDrug
Also called Diabex tab
Day 29 to 56: Metformin 500mg bid
PlaceboDrug
Day 1 to 56: Placebo bid
| Study group | Role | What they receive |
|---|---|---|
| UDCA 8 wks | Experimental | Day 1 to 56: Ursodeoxycholic acid 300mg bid Receives: Drug: Ursodeoxycholic acid |
| UDCA for 4wks/UDCA+metformin for 4wks | Experimental | Day 1 to 28: Ursodeoxycholic acid 300mg bid Day 29 to 56: Ursodeoxycholic acid 300mg and Metformin 500mg bid Receives: Drug: Ursodeoxycholic acid; Drug: Metformin |
| Placebo | Placebo comparator | Day 1 to 56: Placebo bid Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid
Measured: Day 1, 15, 29, 57 predose (0h), Day 29 1, 2, 3, 4h
Change from Baseline Low-density lipoprotein cholesterol at 8 weeks
Measured: Day 1, 29, 57, 71 predose (0h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Yong Chung, MD, PhD, Seoul National University Hospital
- Investigators
- Jae-Yong Chung, M.D., Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000218
- Sponsor's protocol ID
- UDCA_overweight_LFTabnormal
- Status last verified
- Dec 2016
- First submitted
- 21 Jun 2016
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating Pharmacokinetics and Biomarkers After Ursodeoxycholic Acid (UDCA) Administration to Subjects Who Are Overweight and Have Liver Problems
- ClinicalTrials.gov ID
- NCT03000218
- Acronym / sponsor ID
- UDCA_overweight_LFTabnormal
- Conditions
- Overweight, Abnormal Liver Function Tests
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (estimated)
- First posted
- 21 Dec 2016 (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.
A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid multiple administration
Detailed description
This study has a randomized, open-label, three-treatment, one-sequence, placebo-controlled, multiple drug administration design. The purpose of this study is as follows; To evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UDCA 8 wks | Experimental | Drug: Ursodeoxycholic acidDay 1 to 56: Ursodeoxycholic acid 300mg bid |
| UDCA for 4wks/UDCA+metformin for 4wks | Experimental | Drug: Ursodeoxycholic acid, Drug: MetforminDay 1 to 28: Ursodeoxycholic acid 300mg bid Day 29 to 56: Ursodeoxycholic acid 300mg and Metformin 500mg bid |
| Placebo | Placebo comparator | Drug: PlaceboDay 1 to 56: Placebo bid |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Subjects aged 18 - 50 years
- A body mass index (BMI) in the range of 25.0 kg/m2 - 30.0 kg/m2.
- A alanine aminotransferase (ALT) in the range of 40 - 200 IU/L
- Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.
Key exclusion criteria (2 listed)
- Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
- Subject judged not eligible for study participation by investigator
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 |
|---|---|---|
| Ursodeoxycholic acidAlso: Ursa tabUrsodeoxycholic acid 300mg bid for 8 weeks | Drug | UDCA 8 wks, UDCA for 4wks/UDCA+metformin for 4wks |
| MetforminAlso: Diabex tabDay 29 to 56: Metformin 500mg bid | Drug | UDCA for 4wks/UDCA+metformin for 4wks |
| PlaceboDay 1 to 56: Placebo bid | Drug | Placebo |
Primary outcome
Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid
Time frame: Day 1, 15, 29, 57 predose (0h), Day 29 1, 2, 3, 4h
Change from Baseline Low-density lipoprotein cholesterol at 8 weeks
Time frame: Day 1, 29, 57, 71 predose (0h)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
So Hee Jung contact
Heecahn Lee contact
Jae-Yong Chung, M.D., Ph.D principal investigator
Seoul National University Hospital
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 Ursodeoxycholic acid and Metformin in people with Overweight and Abnormal Liver Function Tests, run by Seoul National University Hospital 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 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 23 Dec 2016. 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. Some participants in this study may receive a placebo. 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 So Hee Jung (+82-31-787-3968), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid (time frame: Day 1, 15, 29, 57 predose (0h), Day 29 1, 2, 3, 4h). The study lists 2 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 2016.