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

Phase 1

Completed

• Conditions: Simvastatin Pharmacokinetics and Gut Microbiome
• Interventions: Drug: Vancomycin 250Mg Capsule

• Registration Number: NCT03403972
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-15
• Study Start: 2017-12-06
• Status Verified: 2018-01
• Primary Completion: 2018-01-11
• Study Completion: 2018-01-11
• Study First Submitted QC: 2018-01-18
• Last Update Submitted: 2018-01-18
• Study First Posted: 2018-01-19
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group	Vancomycin 250Mg Capsule	Intervention: vancomycin 500 mg tid for 7 days (Vancozin 250 mg capsule)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Explore the gut microbiome species change	vancomycin PO will administered for 7 days	Explore how the gut microbiome species change after vancomycin multiple dosing for 7 days

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of