Seoul National University Hospital Clinical Trial Center
Seoul, 03080, South Korea
Completed
NCT Number: NCT03403972
Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers
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.
Completed
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Notify MeKey information
Age range
19 year–50 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Vancomycin 250Mg Capsule
DrugInvestigators will compare simavastatin pharmacokinetics before and after the vancomycin PO multiple administration.
Other names: simvastatin
Primary outcomes
-
Compare the maximum plasma concentration (Cmax)
Time frame: 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)
Time frame: 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 outcomes
-
Explore the gut microbiome species change
Time frame: vancomycin PO will administered for 7 days
Explore how the gut microbiome species change after vancomycin multiple dosing for 7 days
Sponsors and collaborators
Lead sponsor
Seoul National University Hospital
Other
Registry information
Official study 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
Important dates
- Study start
- 2017
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Jan 19, 2018
- Registry last updated
- Jan 19, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.