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

Aged Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02789644
• Other study ID #: UDCA_elderly
• Status: Recruiting
• Phase: Phase 1
• First received: May 31, 2016
• Last updated: May 31, 2016
• Start date: May 2016
• Est. completion date: July 2016

Study information

• Verified date: May 2016
• Source: Seoul National University Hospital
• Contact: Jae-Yong Chung, M.D., Ph.D
• Phone: +82-031-787-3955
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years to 84 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aged

Intervention

Drug:
• Ursodeoxycholic Acid
Day 1: Ursodeoxycholic acid 400mg or 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid		predose and 2, 4, 5, 7, 9, 10, 12, 24h postdose	No