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Completed

NCT Number: NCT03809260

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

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.

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Key information

Conditions

Human Microbiome

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

SNUBH Clinical trial centor

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: Diabex Tab., 500 mg

Vancomycin

Drug

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

Other names: Vancozin cap., 250 mg

Metformin (part 2)

Drug

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

Other names: Diabex Tab., 500 mg

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Clinical Trial for Analysis of Intestinal Microbiome Affecting Pharmacokinetics, Pharmacodynamics, and Safety of Metformin in Healthy Volunteers

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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