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

Not Applicable

Completed

• Conditions: Human Microbiome
• Interventions: Drug: Metformin (part 2); Drug: Metformin (part 1); Drug: Vancomycin

• Registration Number: NCT03809260
• Lead Sponsor: Seoul National University 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part 2	Metformin (part 2)	Metformin
Part 1	Metformin (part 1)	Metformin/Vancomycin
Part 1	Vancomycin	Metformin/Vancomycin

Primary Outcome Measures

Name	Time	Method
Compare the gut microbiome species change	Day 1/4/16/19	Compare how the gut microbiome species change after metformin (or vancomycin) multiple dosing

Secondary Outcome Measures

Name	Time	Method
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 plasma concentration (Cmax) of metformin before and after vancomycin PO treatment
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)	Oral glucose tolerance test (OGTT); Compare the maximum blood glucose concentration (Gmax) before and after metformin (or vancomycin) PO treatment
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 plasma concentration versus time curve (AUC) of metformin before and after vancomycin PO treatment
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)	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

Trial Locations

Locations (1)

SNUBH Clinical trial centor; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of