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

Phase 1

• Conditions: Overweight; Abnormal Liver Function Tests
• Interventions: Drug: Ursodeoxycholic acid; Drug: Placebo; Drug: Metformin

• Registration Number: NCT03000218
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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 Timeline

• Study First Submitted: 2016-06-21
• Study Start: 2016-08
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-21
• Last Update Submitted: 2016-12-22
• Last Update Posted: 2016-12-23
• Primary Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UDCA 8 wks	Ursodeoxycholic acid	Day 1 to 56: Ursodeoxycholic acid 300mg bid
UDCA for 4wks/UDCA+metformin for 4wks	Metformin	Day 1 to 28: Ursodeoxycholic acid 300mg bid Day 29 to 56: Ursodeoxycholic acid 300mg and Metformin 500mg bid
Placebo	Placebo	Day 1 to 56: Placebo bid
UDCA for 4wks/UDCA+metformin for 4wks	Ursodeoxycholic acid	Day 1 to 28: Ursodeoxycholic acid 300mg bid Day 29 to 56: Ursodeoxycholic acid 300mg and Metformin 500mg bid

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of