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

Human Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809260
• Other study ID #: MMP
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: October 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Human Microbiome

Intervention

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).
• Vancomycin
11d: Vancomycin 250 mg bid, 12~17d: Vancomycin 500 mg bid
• Metformin (part 2)
1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch)

Locations

Country	Name	City	State
Korea, Republic of	SNUBH Clinical trial centor	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the gut microbiome species change	Compare how the gut microbiome species change after metformin (or vancomycin) multiple dosing	Day 1/4/16/19
Secondary	Compare the maximum plasma concentration (Cmax) of metformin	Compare the maximum plasma concentration (Cmax) of metformin before and after vancomycin PO treatment	Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)
Secondary	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	Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)
Secondary	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	Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
Secondary	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	Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)