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

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ClinicalTrials.gov Identifier: NCT03809260
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jae Yong Chung, MD, PhD, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Human Microbiome Drug: Metformin (part 1) Drug: Vancomycin Drug: Metformin (part 2) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Clinical Trial for Analysis of Intestinal Microbiome Affecting Pharmacokinetics, Pharmacodynamics, and Safety of Metformin in Healthy Volunteers
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1
Metformin/Vancomycin
Drug: Metformin (part 1)
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).
Other Name: Diabex Tab., 500 mg

Drug: Vancomycin
11d: Vancomycin 250 mg bid, 12~17d: Vancomycin 500 mg bid
Other Name: Vancozin cap., 250 mg

Experimental: Part 2
Metformin
Drug: Metformin (part 2)
1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch)
Other Name: Diabex Tab., 500 mg




Primary Outcome Measures :
  1. Compare the gut microbiome species change [ Time Frame: Day 1/4/16/19 ]
    Compare how the gut microbiome species change after metformin (or vancomycin) multiple dosing


Secondary Outcome Measures :
  1. Compare the maximum plasma concentration (Cmax) of metformin [ 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 plasma concentration (Cmax) of metformin before and after vancomycin PO treatment

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

  3. Compare the maximum blood glucose concentration (Gmax) [ Time Frame: Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours) ]
    Oral glucose tolerance test (OGTT); Compare the maximum blood glucose concentration (Gmax) before and after metformin (or vancomycin) PO treatment

  4. Compare the area under the blood glucose concentration versus time curve (AUC) [ Time Frame: Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours) ]
    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



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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809260


Locations
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Korea, Republic of
SNUBH Clinical trial centor Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 03080
Contact: Jae-Yong Chung    +82-31-787-3968    mekka@snu.ac.kr   
Principal Investigator: Jae-Yong Chung, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Jae Yong Chung, MD, PhD, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03809260     History of Changes
Other Study ID Numbers: MMP
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Metformin
Vancomycin
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents