Evaluation of PK and Biomarkers After UDCA Administrations to Subjects Who Are Overweight and Have Liver Problems

Study Overview
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Brief Summary
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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
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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

Official Title
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Clinical Study Evaluating Pharmacokinetics and Biomarkers After Ursodeoxycholic Acid (UDCA) Administration to Subjects Who Are Overweight and Have Liver Problems

Conditions
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Overweight, Abnormal Liver Function Tests

Intervention / Treatment
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* Drug: Ursodeoxycholic acid
* Drug: Metformin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UDCA 8 wks<br>Day 1 to 56: Ursodeoxycholic acid 300mg bid | Drug: Ursodeoxycholic acid<br>* Ursodeoxycholic acid 300mg bid for 8 weeks<br>* Other names: Ursa tab;|
| Experimental: UDCA for 4wks/UDCA+metformin for 4wks<br>Day 1 to 28: Ursodeoxycholic acid 300mg bid Day 29 to 56: Ursodeoxycholic acid 300mg and Metformin 500mg bid | Drug: Ursodeoxycholic acid<br>* Ursodeoxycholic acid 300mg bid for 8 weeks<br>* Other names: Ursa tab;Drug: Metformin<br>* Day 29 to 56: Metformin 500mg bid<br>* Other names: Diabex tab;|
| Placebo Comparator: Placebo<br>Day 1 to 56: Placebo bid | Drug: Placebo<br>* Day 1 to 56: Placebo bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid |  | Day 1, 15, 29, 57 predose (0h), Day 29 1, 2, 3, 4h | 
| Change from Baseline Low-density lipoprotein cholesterol at 8 weeks |  | Day 1, 29, 57, 71 predose (0h) |