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

NCT03000218 | Unknown Phase 1

• 1 other identifier: UDCA_overweight_LFTabnormal
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight; Abnormal Liver Function Tests

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (3)

UDCA 8 wks

EXPERIMENTAL

Day 1 to 56: Ursodeoxycholic acid 300mg bid

Drug: Ursodeoxycholic acid

UDCA for 4wks/UDCA+metformin for 4wks

EXPERIMENTAL

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

Drug: Ursodeoxycholic acid; Drug: Metformin

Placebo

PLACEBO COMPARATOR

Day 1 to 56: Placebo bid

Drug: Placebo

Interventions

Ursodeoxycholic acid DRUG

Ursodeoxycholic acid 300mg bid for 8 weeks

Also known as: Ursa tab

UDCA 8 wks; UDCA for 4wks/UDCA+metformin for 4wks

Metformin DRUG

Day 29 to 56: Metformin 500mg bid

Also known as: Diabex tab

UDCA for 4wks/UDCA+metformin for 4wks

Placebo DRUG

Day 1 to 56: Placebo bid

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Overweight

Interventions

Ursodeoxycholic Acid; Metformin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Jae-Yong Chung, M.D., Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

So Hee Jung

CONTACT

+82-31-787-3968

Heecahn Lee

CONTACT

+82-2-2072-4083

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: December 21, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Last Updated: December 23, 2016

Record last verified: 2016-12

Locations

KR (1)