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Status unknownNCT02789644Updated Jun 3, 2016

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

A Phase 1 interventional study of Ursodeoxycholic Acid in Aged, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 70 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-03.

Sponsored by Seoul National University Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
70 Years to 84 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Aged

Keywords

  • Ursodeoxycholic acid
  • Metabolomics/biomarker
  • Pharmacokinetics
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Ursodeoxycholic acid 400mg

    Day 1: Ursodeoxycholic acid 400mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid

    Drug: Ursodeoxycholic Acid

  • Experimental
    Ursodeoxycholic acid 800mg

    Day 1: Ursodeoxycholic acid 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid

    Drug: Ursodeoxycholic Acid

Interventions

  • DrugUrsodeoxycholic Acid

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

    Also known as: Ursa tab.

06

What researchers measure

Primary outcomes

  1. Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid

    Time frame: predose and 2, 4, 5, 7, 9, 10, 12, 24h postdose

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Bundang Hospital
    Seoul, Korea, Republic of
    • Jae-Yong Chung, MD, PhD · Contact · +82-031-787-3955
    • Jae-Yong Chung, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02789644
Lead sponsor
Seoul National University Hospital
Responsible party
Jae Yong Chung (M.D., Ph.D, Seoul National University Hospital) — Principal investigator
First posted
Jun 3, 2016
Start date
May 2016
Primary completion
Jul 2016 (estimated)
Completion
Jul 2016 (estimated)
Last update
Jun 3, 2016

Study contacts

Jae-Yong Chung, M.D., Ph.D
Contact
+82-031-787-3955
Jae-Yong Chung, M.D., Ph.D
principal investigator · Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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