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

Seoul National University

Status and phase: Unknown; Phase 1

Conditions: Abnormal Liver Function Tests; Overweight

Treatments: Drug: Metformin; Drug: Ursodeoxycholic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03000218

UDCA_overweight_LFTabnormal

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups, including a placebo group

UDCA 8 wks

Experimental group

Description:

Day 1 to 56: Ursodeoxycholic acid 300mg bid

Treatment:

Drug: Ursodeoxycholic acid

UDCA for 4wks/UDCA+metformin for 4wks

Experimental group

Description:

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

Treatment:

Drug: Ursodeoxycholic acid

Drug: Metformin

Placebo

Placebo Comparator group

Description:

Day 1 to 56: Placebo bid

Treatment:

Drug: Placebo