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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03000218

Enrollment

Registered

2016-12-21

Start date

2016-08-31

Completion date

Unknown

Last updated

2016-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Liver Function Tests, Overweight

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

Interventions

DRUGUrsodeoxycholic acid

Ursodeoxycholic acid 300mg bid for 8 weeks

DRUGMetformin

Day 29 to 56: Metformin 500mg bid

DRUGPlacebo

Day 1 to 56: Placebo bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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)

Countries

South Korea

Contacts

Primary ContactSo Hee Jung

+82-31-787-3968

Backup ContactHeecahn Lee

+82-2-2072-4083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026