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Clinical Trials/NCT03809260
NCT03809260CompletedNot Applicable

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

Seoul National University Hospital1 site in 1 country20 target enrollmentStarted: December 1, 2018Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Compare the gut microbiome species change
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
19 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Part 1

Experimental

Metformin/Vancomycin

Intervention: Metformin (part 1) (Drug)

Part 1

Experimental

Metformin/Vancomycin

Intervention: Vancomycin (Drug)

Part 2

Experimental

Metformin

Intervention: Metformin (part 2) (Drug)

Outcomes

Primary Outcomes

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

  • 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 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 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 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jae Yong Chung, MD, PhD

Professor

Seoul National University Bundang Hospital

Study Sites (1)

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