A Clinical Study to Assess the Effect of Change of Bile Acid on the PD and Safety of Metformin and Microbiome Profiles

Study Overview
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Brief Summary
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This clinical trial is intended to evaluate the effect of change of bile acid pool with cholestyramine on the pharmacodynamics and safety of metformin and intestinal microbiome profiles in healthy volunteers

Official Title
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A Clinical Study for Assessing the Effect of Change of Bile Acid Pool on the Pharmacodynamics and Safety of Metformin and Intestinal Microbiome Profiles in Healthy Volunteers

Conditions
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Human Microbiome

Intervention / Treatment
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* Drug: Cholestyramine Resin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 19 to 50, 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)>2 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Metformin alone<br> | |
| Other: Metformin with cholestyramine<br> | Drug: Cholestyramine Resin<br>* Change bile acid pool by cholestyramine treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the maximum blood glucose concentration (Gmax) | Compare the maximum blood glucose concentration (Gmax) between meformin alone and meformin with cholestyramine | Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours) | 
| Compare the maximum blood glucose concentration (Gmax) | Compare the area under the blood glucose concentration versus time curve (AUC) between meformin alone and meformin with cholestyramine | Day 1/2/8/9 (pre-dose (75 g glucose), 0.25, 0.5, 0.75, 1, 1.5. 2 hours) | 
| Compare the gut microbiome species change | Compare how the gut microbiome species change between meformin alone and meformin with cholestyramine | Day 1/2/8/9 |