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

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

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.

Study Overview

• Status: Completed
• Conditions: Simvastatin Pharmacokinetics and Gut Microbiome
• Intervention / Treatment: Drug: Vancomycin 250Mg Capsule

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: SeungHwan Lee, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2017
• Primary Completion (Actual): January 11, 2018
• Study Completion (Actual): January 11, 2018

Study Registration Dates

• First Submitted: October 15, 2017
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 19, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: pharmacokinetics; gut microbiome; vancomycin; simvastatin
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Anti-Bacterial Agents; Vancomycin; Simvastatin
• Other Study ID Numbers: MBSVT_PK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Investigators have no plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No