Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers

Study Overview
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Brief Summary
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This phase 1 clinical trial is to evaluate the effects of the environmental change in intestine by antibiotics on the pharmacokinetic characteristics of simvastatin in healthy male volunteers. For change of intestine environment, especially the gut microbiota, investigators will administer PO vancomycin for 7 days, tid.

Official Title
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A Clinical Trial to Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers

Conditions
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Simvastatin Pharmacokinetics and Gut Microbiome

Intervention / Treatment
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* Drug: Vancomycin 250Mg Capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 19 Y to 50 Y at the screening Body weight over 55 kg and BMI should be between 18.0 to 25.0 kg/m2 Informed consent will be taken before all the procedures from volunteers SLCO1B1 genotype is *1/*1 when screening Exclusion Criteria: No significant disease history or ongoing disease Allergic to simvastatin and vancomycin, or similar affiliation drug for simvastatin or vancomycin MDRD eGFR less than 60 mL/min/1.73m2 Total cholesterol, LDL, TG is higher than 1.5 times more than upper normal limit at the screening HDL less than 35 mg/dL at the screening Positive HBV or HIV or HCV Who is administering or going to administer CYP3A4 inihibitor drug Other clinically significant situation under doctor's opinion

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group<br>Intervention: vancomycin 500 mg tid for 7 days (Vancozin 250 mg capsule) | Drug: Vancomycin 250Mg Capsule<br>* Investigators will compare simavastatin pharmacokinetics before and after the vancomycin PO multiple administration.<br>* Other names: simvastatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the maximum plasma concentration (Cmax) | Compare the maximum plasma concentration (Cmax) of simvastatin before and after vancomycin PO treatment. | vancomycin PO will administered for 7 days | 
| Compare the area under the time-plasma concentration curve (AUC) | Compare the area under the time-plasma concentration curve (AUC) of simvastatin before and after vancomycin PO treatment. | vancomycin PO will administered for 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore the gut microbiome species change | Explore how the gut microbiome species change after vancomycin multiple dosing for 7 days | vancomycin PO will administered for 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, simvastatin, vancomycin, gut microbiome