NCT02789644

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 3, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

May 31, 2016

Last Update Submit

May 31, 2016

Conditions

Aged

Keywords

Ursodeoxycholic acidMetabolomics/biomarkerPharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (2)

Ursodeoxycholic acid 400mg

EXPERIMENTAL

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

Drug: Ursodeoxycholic Acid

Ursodeoxycholic acid 800mg

EXPERIMENTAL

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

Drug: Ursodeoxycholic Acid

Interventions

Ursodeoxycholic AcidDRUG

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

Also known as: Ursa tab.
Ursodeoxycholic acid 400mgUrsodeoxycholic acid 800mg

Eligibility Criteria

Age70 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Ursodeoxycholic Acid

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Officials

  • Jae-Yong Chung, M.D., Ph.D

    Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae-Yong Chung, M.D., Ph.D

CONTACT

+82-031-787-3955

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
M.D., Ph.D

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 3, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 3, 2016

Record last verified: 2016-05

Locations

KR(1)