NCT03809260

Brief Summary

This clinical trial is intended to evaluate the effects of the changes in intestinal microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety profiles of metformin in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

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

December 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

January 8, 2019

Last Update Submit

October 6, 2020

Conditions

Human Microbiome

Outcome Measures

Primary Outcomes (1)

  • Compare the gut microbiome species change

    Compare how the gut microbiome species change after metformin (or vancomycin) multiple dosing

    Day 1/4/16/19

Secondary Outcomes (4)

  • Compare the maximum plasma concentration (Cmax) of metformin

    Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)

  • Compare the area under the plasma concentration versus time curve (AUC) of metformin

    Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)

  • Compare the maximum blood glucose concentration (Gmax)

    Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)

  • Compare the area under the blood glucose concentration versus time curve (AUC)

    Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)

Study Arms (2)

Part 1

EXPERIMENTAL

Metformin/Vancomycin

Drug: Metformin (part 1)Drug: Vancomycin

Part 2

EXPERIMENTAL

Metformin

Drug: Metformin (part 2)

Interventions

Metformin (part 1)DRUG

1\~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch), 16d\~19d: Metformin 1000 mg bid (Except for 500 mg after 16d lunch).

Also known as: Diabex Tab., 500 mg
Part 1
VancomycinDRUG

11d: Vancomycin 250 mg bid, 12\~17d: Vancomycin 500 mg bid

Also known as: Vancozin cap., 250 mg
Part 1
Metformin (part 2)DRUG

1\~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch)

Also known as: Diabex Tab., 500 mg
Part 2

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 19 to 45, healthy male subjects(at screening)
  • Body weight between 50.0 kg - 100.0 kg, BMI between 18.0 - 28.0 kg/m2
  • Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

You may not qualify if:

  • Subject who has a past or present history of any diseases following below.(liver, kidney, neurology, immunology, pulmonary, endocrine, hematology, oncology, cardiology, mental disorder)
  • Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery (appendectomy, hernioplasty are excluded)
  • Serum AST(SGOT), ALT(SGPT)\>1.5 times upper limit of normal range
  • MDRD eGFR \<80mL/min/1.73m2
  • Subject who had drug (Aspirin, antibiotics) hypersensitivity reaction
  • Subject who already participated in other trials in 3 months
  • Subject who had whole blood donation in 2 months, or component blood donation in 1 month or transfusion in 1 month currently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUBH Clinical trial centor

Seongnam-si, Gyeonggi-do, 03080, South Korea

Location

Related Publications (1)

  • Kim E, Kim AH, Lee Y, Ji SC, Cho JY, Yu KS, Chung JY. Effects of vancomycin-induced gut microbiome alteration on the pharmacodynamics of metformin in healthy male subjects. Clin Transl Sci. 2021 Sep;14(5):1955-1966. doi: 10.1111/cts.13051. Epub 2021 May 31.

    PMID: 33982376DERIVED

MeSH Terms

Interventions

MetforminVancomycin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jae-Yong Chung

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 18, 2019

Study Start

December 1, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)