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NCT02431832 Clinical Trial

Exploration of microRNA and Metabolomics Biomarkers Predicting Drug Induced Liver Injury in Elderly People

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02431832
Other study ID # DILI_Elderly
Secondary ID
Status Completed
Phase Phase 1
First received April 20, 2015
Last updated August 28, 2016
Start date February 2015

Study information
Verified date August 2016
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

An open-label, one-sequence, multiple administration study for exploration of microRNA and metabolomics biomarkers to predict drug induced liver injury in healthy elderly Korean people.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date
Est. primary completion date October 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 65 Years to 84 Years
Eligibility Inclusion Criteria:

- Healthy subjects, as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations were eligible to participate in the study. Subjects had to be 65 to 84 years of age.

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

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Augmentin tab

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 Curve (AUC) up to 35 days No
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