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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03000218
• Other study ID #: UDCA_overweight_LFTabnormal
• Status: Recruiting
• Phase: Phase 1
• First received: June 21, 2016
• Last updated: December 22, 2016
• Start date: August 2016

Study information

• Verified date: December 2016
• Source: Seoul National University Hospital
• Contact: So Hee Jung
• Phone: +82-31-787-3968
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid multiple administration

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormal Liver Function Tests
• Overweight

Intervention

Drug:
• Ursodeoxycholic acid
Ursodeoxycholic acid 300mg bid for 8 weeks
• Metformin
Day 29 to 56: Metformin 500mg bid
• Placebo
Day 1 to 56: Placebo bid

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid		Day 1, 15, 29, 57 predose (0h), Day 29 1, 2, 3, 4h	No
Primary	Change from Baseline Low-density lipoprotein cholesterol at 8 weeks		Day 1, 29, 57, 71 predose (0h)	No