NCT02125305

Brief Summary

This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral administration in healthy elderly male volunteers.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
Last Updated

April 29, 2014

Status Verified

April 1, 2014

Enrollment Period

5 months

First QC Date

April 25, 2014

Last Update Submit

April 28, 2014

Conditions

Healthy Elderly

Keywords

MetforminPharmacokinetics/ Pharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • AUC(area under the plasma concentration-time curve)

    AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2

    Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose

Secondary Outcomes (1)

  • AUGC(total area under the serum concentration-time curve for glucose concentration)

    predose and 15, 30, 45, 60, 90, 120 min oral glucose tolerance test

Study Arms (1)

Metformin

EXPERIMENTAL

Metformin 750mg(D1), Metformin 500mg(D2)

Drug: Metformin

Interventions

MetforminDRUG
Also known as: Diabex
Metformin

Eligibility Criteria

Age65 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Males aged 65-85 years with a body mass index (BMI) of 18-28 kg/m2
  • Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations including hematology (blood cell count, hemoglobin, and platelet count), liver function test (aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin), serum creatinine, blood glucose and urinalysis

You may not qualify if:

  • If they had clinically relevant disorders
  • Past history of diabetes or clinical findings to suspect diabetes
  • Abnormal clinical laboratory values (i.e., platelets ≤ 75,000/mm3, hemoglobin ≤ 9 g/dL, neutrophils absolute ≤ 1000/mm3, fasting glucose \> 126mg/dL, creatinine ≥ 1.5 mg/dL, or AST, ALT \> 3 × upper limit of normal)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jae-Yong Chung, M.D., Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D

Study Record Dates

First Submitted

April 25, 2014

First Posted

April 29, 2014

Study Start

August 1, 2013

Primary Completion

January 1, 2014

Last Updated

April 29, 2014

Record last verified: 2014-04

Locations

KR(1)