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Trial record 42 of 118 for:    URSODIOL

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

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ClinicalTrials.gov Identifier: NCT03000218
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Jae Yong Chung, MD, PhD, 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

Condition or disease Intervention/treatment Phase
Overweight Abnormal Liver Function Tests Drug: Ursodeoxycholic acid Drug: Metformin Drug: Placebo Phase 1

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study Evaluating Pharmacokinetics and Biomarkers After Ursodeoxycholic Acid (UDCA) Administration to Subjects Who Are Overweight and Have Liver Problems
Study Start Date : August 2016
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Ursa tab
Drug: Metformin
Day 29 to 56: Metformin 500mg bid
Other Name: Diabex tab
Placebo Comparator: Placebo
Day 1 to 56: Placebo bid
Drug: Placebo
Day 1 to 56: Placebo bid



Primary Outcome Measures :
  1. 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 ]
  2. Change from Baseline Low-density lipoprotein cholesterol at 8 weeks [ Time Frame: Day 1, 29, 57, 71 predose (0h) ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000218


Contacts
Contact: So Hee Jung +82-31-787-3968
Contact: Heecahn Lee +82-2-2072-4083

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jae-Yong Chung, MD, PhD    +82-031-787-3955      
Principal Investigator: Jae-Yong Chung, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jae-Yong Chung, M.D., Ph.D Seoul National University Hospital

Responsible Party: Jae Yong Chung, MD, PhD, Principal Investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03000218     History of Changes
Other Study ID Numbers: UDCA_overweight_LFTabnormal
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Metformin
Ursodeoxycholic Acid
Hypoglycemic Agents
Physiological Effects of Drugs
Cholagogues and Choleretics
Gastrointestinal Agents