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

Primary Purpose

Overweight, Abnormal Liver Function Tests

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ursodeoxycholic acid
Metformin
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

UDCA 8 wks

UDCA for 4wks/UDCA+metformin for 4wks

Placebo

Arm Description

Day 1 to 56: Ursodeoxycholic acid 300mg bid

Day 1 to 28: Ursodeoxycholic acid 300mg bid Day 29 to 56: Ursodeoxycholic acid 300mg and Metformin 500mg bid

Day 1 to 56: Placebo bid

Outcomes

Primary Outcome Measures

Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid
Change from Baseline Low-density lipoprotein cholesterol at 8 weeks

Secondary Outcome Measures

Full Information

First Posted
June 21, 2016
Last Updated
December 22, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03000218
Brief Title
Evaluation of PK and Biomarkers After UDCA Administrations to Subjects Who Are Overweight and Have Liver Problems
Official Title
Clinical Study Evaluating Pharmacokinetics and Biomarkers After Ursodeoxycholic Acid (UDCA) Administration to Subjects Who Are Overweight and Have Liver Problems
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Abnormal Liver Function Tests

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UDCA 8 wks
Arm Type
Experimental
Arm Description
Day 1 to 56: Ursodeoxycholic acid 300mg bid
Arm Title
UDCA for 4wks/UDCA+metformin for 4wks
Arm Type
Experimental
Arm Description
Day 1 to 28: Ursodeoxycholic acid 300mg bid Day 29 to 56: Ursodeoxycholic acid 300mg and Metformin 500mg bid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Day 1 to 56: Placebo bid
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid
Other Intervention Name(s)
Ursa tab
Intervention Description
Ursodeoxycholic acid 300mg bid for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Diabex tab
Intervention Description
Day 29 to 56: Metformin 500mg bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Day 1 to 56: Placebo bid
Primary Outcome Measure Information:
Title
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
Title
Change from Baseline Low-density lipoprotein cholesterol at 8 weeks
Time Frame
Day 1, 29, 57, 71 predose (0h)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
So Hee Jung
Phone
+82-31-787-3968
First Name & Middle Initial & Last Name or Official Title & Degree
Heecahn Lee
Phone
+82-2-2072-4083
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae-Yong Chung, M.D., Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Yong Chung, MD, PhD
Phone
+82-031-787-3955
First Name & Middle Initial & Last Name & Degree
Jae-Yong Chung, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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