Clinical trial NCT03809260: A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin
Official title: A Clinical Trial for Analysis of Intestinal Microbiome Affecting Pharmacokinetics, Pharmacodynamics, and Safety of Metformin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Microbiome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Compare the gut microbiome species change
timeFrame: Day 1/4/16/19
Secondary outcomes:
measure: Compare the maximum plasma concentration (Cmax) of metformin
timeFrame: Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)
measure: Compare the area under the plasma concentration versus time curve (AUC) of metformin
timeFrame: Day 4/19 (pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post-dose)
measure: Compare the maximum blood glucose concentration (Gmax)
timeFrame: Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
measure: Compare the area under the blood glucose concentration versus time curve (AUC)
timeFrame: Day 1/4/16/19 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: SNUBH Clinical trial centor
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jae-Yong Chung
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim E, Kim AH, Lee Y, Ji SC, Cho JY, Yu KS, Chung JY. Effects of vancomycin-induced gut microbiome alteration on the pharmacodynamics of metformin in healthy male subjects. Clin Transl Sci. 2021 Sep;14(5):1955-1966. doi: 10.1111/cts.13051. Epub 2021 May 31.