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

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Simvastatin Pharmacokinetics and Gut Microbiome

Treatments: Drug: Vancomycin 250Mg Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03403972

MBSVT_PK

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Group

Experimental group

Description:

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

Treatment:

Drug: Vancomycin 250Mg Capsule