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

Simvastatin Pharmacokinetics and Gut Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403972
• Other study ID #: MBSVT_PK
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2017
• Last updated: January 18, 2018
• Start date: December 6, 2017
• Est. completion date: January 11, 2018

Study information

• Verified date: January 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 11, 2018
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Simvastatin Pharmacokinetics and Gut Microbiome

Intervention

Drug:
• Vancomycin 250Mg Capsule
Investigators will compare simavastatin pharmacokinetics before and after the vancomycin PO multiple administration.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital Clinical Trial Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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