Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Elderly After UDCA Administration

May 31, 2016 updated by: Jae Yong Chung, Seoul National University Hospital

A Randomized, Open-label Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Healthy Elderly Subjects After Ursodeoxycholic Acid Administration

A clinical study to investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study has a randomized, open-label, two-treatment, one-sequence, multiple drug administration design. The purpose of this study is as follows; To investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jae-Yong Chung, M.D., Ph.D
  • Phone Number: +82-031-787-3955

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Jae-Yong Chung, MD, PhD
          • Phone Number: +82-031-787-3955
        • Principal Investigator:
          • Jae-Yong Chung, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

68 years to 82 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Subjects aged 70 - 84 years
  • A body mass index (BMI) in the range of 18.5 kg/m2 - 29.9 kg/m2.
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ursodeoxycholic acid 400mg
Day 1: Ursodeoxycholic acid 400mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid
Drug: Ursodeoxycholic Acid
Day 1: Ursodeoxycholic acid 400mg or 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid
Other Names:
  • Ursa tab.
Experimental: Ursodeoxycholic acid 800mg
Day 1: Ursodeoxycholic acid 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid
Drug: Ursodeoxycholic Acid
Day 1: Ursodeoxycholic acid 400mg or 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid
Other Names:
  • Ursa tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid
Time Frame: predose and 2, 4, 5, 7, 9, 10, 12, 24h postdose
predose and 2, 4, 5, 7, 9, 10, 12, 24h postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jae-Yong Chung, M.D., Ph.D, Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDCA_elderly

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aged

Clinical Trials on Ursodeoxycholic Acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe