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CompletedNCT03403972Updated Jan 19, 2018

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

A Phase 1 interventional study of Vancomycin 250Mg Capsule in Simvastatin Pharmacokinetics and Gut Microbiome, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-19.

Sponsored by Seoul National University Hospital · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
19 Years to 50 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Simvastatin Pharmacokinetics and Gut Microbiome

Keywords

  • pharmacokinetics
  • simvastatin
  • vancomycin
  • gut microbiome
03

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
Male
Accepts 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

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
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Group

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

    Drug: Vancomycin 250Mg Capsule

Interventions

  • DrugVancomycin 250Mg Capsule

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

    Also known as: simvastatin

05

What researchers measure

Primary outcomes

  1. Compare the maximum plasma concentration (Cmax)

    Compare the maximum plasma concentration (Cmax) of simvastatin before and after vancomycin PO treatment.

    Time frame: vancomycin PO will administered for 7 days

  2. 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.

    Time frame: vancomycin PO will administered for 7 days

Secondary outcomes

  1. Explore the gut microbiome species change

    Explore how the gut microbiome species change after vancomycin multiple dosing for 7 days

    Time frame: vancomycin PO will administered for 7 days

06

Study locations

1 site
  • Seoul National University Hospital Clinical Trial Center
    Seoul, 03080, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No — Investigators have no plan to share individual participant data.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03403972
Lead sponsor
Seoul National University Hospital
Responsible party
SeungHwan Lee (Clinical Assistant Professor, Seoul National University Hospital) — Principal investigator
First posted
Jan 19, 2018
Start date
Dec 6, 2017
Primary completion
Jan 11, 2018
Completion
Jan 11, 2018
Last update
Jan 19, 2018

Study contacts

SeungHwan Lee, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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