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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03403972

Enrollment

Registered

2018-01-19

Start date

2017-12-06

Completion date

2018-01-11

Last updated

2018-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simvastatin Pharmacokinetics and Gut Microbiome

Keywords

pharmacokinetics, simvastatin, vancomycin, gut microbiome

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.

Interventions

DRUGVancomycin 250Mg Capsule

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026