A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin

Seoul National University Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Human Microbiome

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).

VancomycinDRUG

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

Metformin (part 2)DRUG

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

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

SNUBH Clinical trial centor

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Compare the gut microbiome species change

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

Time frame: Day 1/4/16/19

Secondary Outcomes

Compare the maximum plasma concentration (Cmax) of metformin

Compare the maximum plasma concentration (Cmax) of metformin before and after vancomycin PO treatment

Time frame: 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

Compare the area under the plasma concentration versus time curve (AUC) of metformin before and after vancomycin PO treatment

Time frame: 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)

Oral glucose tolerance test (OGTT); Compare the maximum blood glucose concentration (Gmax) before and after metformin (or vancomycin) PO treatment

Time frame: 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)

Oral glucose tolerance test (OGTT); Compare the area under the blood glucose concentration versus time curve (AUC) before and after metformin (or vancomycin) PO treatment

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

Data from ClinicalTrials.gov

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