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

December 22, 2016 updated by: Jae Yong Chung, MD, PhD, Seoul National University Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Jae-Yong Chung, MD, PhD
          • Phone Number: +82-031-787-3955
        • Principal Investigator:
          • Jae-Yong Chung, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UDCA 8 wks
Day 1 to 56: Ursodeoxycholic acid 300mg bid
Drug: Ursodeoxycholic acid
Ursodeoxycholic acid 300mg bid for 8 weeks
Other Names:
  • Ursa tab
Experimental: UDCA for 4wks/UDCA+metformin for 4wks
Day 1 to 28: Ursodeoxycholic acid 300mg bid Day 29 to 56: Ursodeoxycholic acid 300mg and Metformin 500mg bid
Drug: Ursodeoxycholic acid
Ursodeoxycholic acid 300mg bid for 8 weeks
Other Names:
  • Ursa tab
Drug: Metformin
Day 29 to 56: Metformin 500mg bid
Other Names:
  • Diabex tab
Placebo Comparator: Placebo
Day 1 to 56: Placebo bid
Drug: Placebo
Day 1 to 56: Placebo bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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)
Day 1, 29, 57, 71 predose (0h)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jae-Yong Chung, M.D., Ph.D, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (Estimate)

December 21, 2016

Study Record Updates

Last Update Posted (Estimate)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 22, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDCA_overweight_LFTabnormal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight

Clinical Trials on Ursodeoxycholic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe