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

NCT ID: NCT03403972

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-06
• Study Completion Date: 2018-01-11

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.

Conditions

Simvastatin Pharmacokinetics and Gut Microbiome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group

Intervention: vancomycin 500 mg tid for 7 days (Vancozin 250 mg capsule)

Group Type: EXPERIMENTAL

Vancomycin 250Mg Capsule

Intervention Type: DRUG

Investigators will compare simavastatin pharmacokinetics before and after the vancomycin PO multiple administration.

Interventions

Vancomycin 250Mg Capsule

Investigators will compare simavastatin pharmacokinetics before and after the vancomycin PO multiple administration.

Intervention Type: DRUG

Other Intervention Names

simvastatin

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

SeungHwan Lee

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SeungHwan Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital Clinical Trial Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

MBSVT_PK

Identifier Type: -

Identifier Source: org_study_id