Evaluation of PK and Biomarkers After UDCA Administration... | NCT03000218

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

NCT03000218

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Dec 23, 2016Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Overweight
Abnormal Liver Function Tests

Interventions

Ursodeoxycholic acid
Metformin
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Jun 2017Estimated

Completion Date

Not provided

First Submitted Date

Jun 21, 2016

First Submission Date that Met QC Criteria

Dec 19, 2016

First Posted Date

Dec 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2016

Last Update Posted Date

Dec 23, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jae Yong Chung, MD, PhD, Principal Investigator, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ursodeoxycholic acid	Drug	Ursodeoxycholic acid 300mg bid for 8 weeks	UDCA 8 wks UDCA for 4wks/UDCA+metformin for 4wks

Outcomes Module

Primary Outcomes

Measure	Description	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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
So Hee Jung	Contact	+82-31-787-3968
Heecahn Lee	Contact	+82-2-2072-4083

Overall Officials

Name	Affiliation	Role
Jae-Yong Chung, M.D., Ph.D	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014580	Ursodeoxycholic Acid
D008687	Metformin

Ancestor Terms

ID	Term
D003840	Deoxycholic Acid
D002793	Cholic Acids
D001647	Bile Acids and Salts
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided